Dipity
TechDevice is pleased to announce the introduction of its new TDXPress line of stock and standard balloon products. TDXPress stock offerings are ready for immediate shipment and standard options ca...
FDA schedules an internal meeting to discuss the next steps for handling device controversies within CDRH. Donna-Bea Tillman, director of the Office of Device Evaluation, sent an e-mail two weeks p...
FDA announces that Plan B morning-after birth control may be sold over-the-counter to women and men aged 17 and younger. This follows a federal judge’s decision in March 2009 that orders the agency...
Changes in the code emphasize increased restrictions on promotional items and gifts. They also include clarified guidelines for conduct for entering into royalty arrangements and introduce paramete...
The collapse of Lehman Brothers puts thousands of people out of work worldwide. The investment bank is one of the first major casualties of the global credit crisis. Also in September, the securiti...
Norman Noble, Inc. expands facilities with major expansion of its Orthopedic Implant Manufacturing Operations.
In the United States, the national average price for a gallon of regular gasoline rises to an all-time high of $4.11. Diesel costs $4.85 per gallon. The high prices are partially driven by growing ...
The world’s first airway transplant is performed at the Hospital Clinic at the University of Barcelona. Doctors replace a section of Claudia Castillo’s windpipe using a donated organ that is partia...
In the United States, cases of the Salmonella St. Paul strain are first reported. The outbreak is linked to tomatoes, Serrano and jalapeño peppers, and cilantro, which forces restaurants to remove ...
FDA announces that the contamination of blood thinner Heparin may have been intentional. The agency says that an active pharmaceutical ingredient was substituted in the drug during the manufacturin...
Plastics One, Inc., medical component design and manufacturer with 60 years in business, announces the completion of a 15,000 sq. ft. addition, bringing the facility to 80.000 sq. ft.
At the Henri-Mondor Hospital in France, Pascal Coler receives what is considered the world’s first full face transplant. Toward the end of the year, the first face transplant in the United States i...
IW MinVasive introduced thin-walled PTFE line polyimide and Pebax tubing
MD&DI starts to include in every issue an online table of contents, which features information about online exclusives, videos, and extended articles.
Professional baseball is turned on its head with the release of the Mitchell Report, a 409-page investigational report from former senator George Mitchell that details the use of illegal performanc...
Five orthopedic companies settle with the U.S. Department of Justice over allegations that they may have paid kickbacks to surgeons in return for favoring their hip and knee implants. The five are ...
CDRH announces that two pathways for submitting electronic medical device reports (MDRs) are available: CeSub (low volume) and HL7 (high volume).
Apple announces the sale of the 100,000,000th iPod, making the iconic device the fastest-selling music player in history.
FDA unveils a site that shows the status of postapproval patient studies for certain recently approved medical devices.
Former FDA commissioner Lester Crawford is sentenced to three years of supervised probation and fined $90,000. He had previously pled guilty to conflict of interest and false reporting of informati...
Eli Lilly debuts the first insulin pen with a memory chip. It features a digital display that allows patients to record and review their last 16 insulin doses.
FDA and the Veterans Health Administration (VHA) sign an agreement to share information and expertise related to the review and use of FDA-regulated medical products. The partnership is part of FDA...
President Bush signs an executive order that makes it harder for federal agencies to issue policy guidances. Critics say the guidances are back-door attempts to impose regulations.
FDA lifts its 14-year ban on silicone gel breast implants.
FDA approves the Merck’s cervical cancer vaccine Gardasil. It is the first vaccine developed to prevent cervical cancer, genital warts, and precancerous genital lesions from certain strains of HPV,...
FDA and the CDC investigate reports of fungal keratitis infections in contact lens wearers, which leads to Bausch & Lomb’s permanent removal of its ReNu with MoistureLoc products.
Surgeons in France perform the world's first face transplant, although not of a whole face. A 38-year-old woman severely disfigured by a dog attack receives a partial triangular graft, consisting o...
Avian influenza (H5N1) pandemic is considered a global threat. On September 29, 2005, David Nabarro, the newly appointed Senior United Nations System Coordinator for Avian and Human Influenza, warn...
The Senate confirms Lester M. Crawford as FDA commissioner by a vote of 78–16 after a long delay due to controversy over a review of a morning-after contraceptive pill. Crawford resigns two months ...
MD&DI names the top 10 technologies in medical devices based on reader polls.
Researchers in Michigan develop a robot with a sense of touch. They plan to use the device to perform remote breast examinations. Photo courtesy of Kurt Stepnitz, Michigan State University.
Norman Noble, Inc. opens its 3rd facility which provides 120,000 sq. ft. of additional manufacturing space for medical implants and devices.
The medical device industry is well known for its technology, a central aspect that MD&DI covers in each and every issue. Less often noted are the many outstanding people without whom that technolo...
David W. Feigal Jr., who has led the center since 1999; oversaw a major restructuring that included the implementation of user fees, more outreach to outside experts, and expanded educational progr...
Lester Crawford, DVM, the current FDA deputy commissioner, becomes the agency's acting commissioner. Crawford has served as deputy commissioner since McClellan's appointment.
President Bush nominates FDA commissioner Mark B. McClellan, MD, PhD, to become the next administrator of the Centers for Medicare and Medicaid Services.
FDA amends its regulations and requires that the content of labeling be submitted to FDA electronically for new drug applications, abbreviated drug applications, certain biologics license applicati...
President Bush signs the Medicare Prescription Drug, Improvement and Modernization Act (MMA) of 2003. The act expands the Medicare benefit package to include coverage for outpatient prescription dr...
The magazine introduces a redesign in 2003, as well as the first Guide to Outsourcing supplement in March.
www.medtech-grp.com/Site/ID/StapleFormingCustomAutomation.html
Before drug-eluting stents (DES) were approved by FDA, the Centers for Medicare and Medicaid Services takes the unprecedented step of providing for their reimbursement. As a result, the reimburseme...
America begins its war against Iraq by launching missiles and bombs. In an address to the nation, President Bush says, “American and coalition forces are in the early stages of military operations ...
Severe acute respiratory syndrome (SARS) spreads to more than two dozen countries after being reported in February. According to the World Health Organization, the outbreak sickened 8,098 people. O...
Space Shuttle Columbia disintegrates over east Texas while making its landing descent. The disaster kills all seven astronauts. It marks the first time in American space flight history that there h...
The Contak CD/Easytrak system receives FDA approval, becoming the first device approved to offer heart failure patients both an implantable cardioverter defibrillator (ICD) and cardiac resynchroniz...
Bluetooth wireless technology appears on the cover of MD&DI for the first time.
MD&DI gives readers an exclusive guide to microfabrication and how they can incorporate the trendy technique into manufacturing.
Letters contaminated with anthrax spores are sent to news media, Senate majority leader Tom Daschle (D–SD), and senator Patrick Leahy (D–VT). The anthrax attacks infect 22 people, killing five.
Terrorists hijack four planes in the largest attack on American soil.
HHS announces that a scientific review panel, led by the National Institutes of Health, confirms the effectiveness of condoms against the spread of HIV/AIDS. However, the panel also concludes that ...
FDA approves Mentor Corp.’s investigational device exemption study for more cohesive silicone breast implants for a limited number of augmentation, reconstruction, and revision patients.
FDA Consumer Magazine points to the emerging trend in home healthcare, led by smart devices, customized wearable devices, and wireless systems.
The Department of Health and Human Services enacts privacy standards for medical records.
Debate over reprocessing single-use devices heats up in MD&DI.
A preliminary draft of genomes, as part of the Human Genome Project, is completed by J. Craig Venter and Francis Collins.
The first hand transplant surgery is conducted in the United States. Photo courtesy of Jewish Hospital; Kleinert, Kutz and Associates Hand Care Center; and University of Louisville.
The House of Representatives approves the impeachment of President Bill Clinton on grounds of perjury to a grand jury and obstruction of justice. The impeachment stems from Clinton’s involvement wi...
Two research teams working independently report success in isolating and culturing stem cells obtained from human embryos and fetuses. One research team works under James Thomson at the University ...
Jane Henney, MD, is confirmed as FDA commissioner. She has previously served as deputy commissioner for operations at FDA.
A federal appeals court in Richmond, VA, rules that FDA has no authority to regulate tobacco. This decision invalidates FDA actions to restrict the use of cigarette use among minors.
The U.S. government has a federal budget surplus of $69 billion for fiscal year 1998—the first budget surplus since 1969. The government also reduces federal debt held by the public by more than $5...
FDA approves the first computer-aided detection (CAD) device that helps radiologists display and interpret mammograms. Made by Hologic Inc., the Imagechecker M1000 converts a film mammogram into a ...
The European Union passed the Medical Devices Directive in 1993, but allowed a five-year transition period for member states to comply with the law. The directive’s main objective is to harmonize p...
FDA approves Viagra to treat impotence. Pfizer Pharmaceuticals markets Viagra, which becomes the fastest-selling drug in history. Image Caption: Viagra is the first oral pill to treat impotence.
In January 1998, MD&DI launches a series on ISO 10993 biocompatibility. The 11-part series covers such topics as hemocompatibility, genotoxicity, and implant effects.
The film “Titanic,” starring Kate Winslet and Leonardo DiCaprio, is released. It goes on to become the highest-grossing film of all time, earning nearly $2 billion worldwide.
The FDA Modernization Act of 1997 is signed into law. One notable result from the law is the creation of FDA’s Accredited Persons program to improve the efficiency and timeliness of the 510(k) proc...
Reports show that the popular drug combination Fen-Phen causes heart-valve damage. The drug fenfluramine, which is one half of the combo, is voluntarily pulled from the market.
MD&DI receives its first redesign in almost nine years. Help Desk and R&D Horizons debut, and the Products & Services section is now printed in color. Photo courtesy of Aydin Displays
CDRH publishes the first edition of the Medical Device Quality Systems Manual.
The world’s first cloned sheep, Dolly, is born at the Roslin Institute in Scotland. Ian Wilmut and his colleagues clone the animal using cells from the mammary gland, and thus name the sheep after ...
Medical Device Link, the premier online site for the medical device industry, debuts at www.devicelink.com.
The PDA (personal digital assistant) era begins as Palm’s Computing Pilot, the first generation of PDAs, hits the market. The Pilot 1000 sells for $299, and the Pilot 5000 costs $369. The Pilots ar...
FDA approves first antigen test kit to screen blood donors for HIV. The Coulter HIV-1 p24 Antigen Assay is manufactured by Coulter Corp. (Miami) and marketed by Ortho Diagnostic Systems Inc., a sub...
FDA proposes a rule to regulate certain tobacco products containing nicotine on the basis that they meet the legal definition of drugs under the federal Food, Drug, and Cosmetic Act. From 1995 to 1...
Norman Noble, Inc. develops proprietary laser technology to manufacture stents.
The epidemic of Ebola virus infection in Zaire results in more than 300 cases and a death rate of about 80%.
Timothy McVeigh and Terry Nichols use a truck bomb to destroy the Alfred P. Murrah Federal Building, a government office complex in downtown. It is the most significant act of domestic terrorism in...
In five coordinated attacks, perpetrators release sarin on several lines of the Tokyo Metro, killing a dozen people, severely injuring fifty, and causing temporary vision problems for nearly a thou...
HHS Secretary Donna E. Shalala announces the appointment of Sharon Smith Holston as deputy commissioner for external affairs of FDA.
MD&M regional show series launched in Minneapolis.
The first Palmaz-Schatz stent is approved for use in the United States for coronary artery applications. It is cited by physicians as a “breakthrough in interventional medicine.” Over the next deca...
FDA commissioner David Kessler starts the MedWatch program. It collects voluntary reports from doctors, nurses, and patients about adverse events related to medical products.
The United States, Canada, Japan, Russia, the European Space Agency, and Brazil start a project to build the International Space Station. This is the largest international scientific project in his...
The NIH (National Institute of Health) Revitalization Act states that women and minority groups should be included as subjects of clinical research. It also specifies that trials should be designed...
Under the leadership of Robert Temple, the Center for Devices and Radiological Health (CDRH) reviews the quality of science in the review and approval of medical devices. The center recommends bett...
A car bomb explodes underneath the World Trade Center in New York City and kills six people. Five men who belonged to the Islamic Group, an organization with suspected links to Al-Qaeda, later rece...
World Leader in medical component design/manufacture. 60 years in business. Facility growth from 22,650 to 80,000 sq. ft. since 1977. ESOP, SBA Award VA, R&D specialists, most modern machinery in c...
Congress passes the Mammography Quality Standards Act, which is meant to ensure access to quality mammographies to detect breast cancer at its earliest and most-treatable stages.
MD&DI introduces its News & Analysis section.
The Medical Device Amendments of 1992 signed into law. The bill “defines certain terms and to establishes a single reporting standard for user facilities, manufacturers, and distributors” with resp...
The Maastricht Treaty is signed, which forms the European Union and leads to the creation of the euro.
The Soviet republics (11 of the 12) form the Commonwealth of Independent States. Four days later, Mikhail Gorbachev resigns as president of the USSR.
The U.S. Department of Labor’s Occupational Safety and Health Administration issues a standard to protect healthcare workers from the risk of bloodborne pathogens. Exposure can occur as a result of...
The first patient to have a battery-powered left-ventricular assist device (LVAD) implanted leaves the hospital. Thermo Cardiosystems Inc. and the Texas Heart Institute developed and tested the dev...
CDRH establishes a reference list program for manufacturers that have pending premarket approval (PMA) applications. The program aims to ensure that no PMA is granted during a period of time that a...
FDA’s rule defining acceptable quality levels for medical gloves becomes effective today. Any gloves sold in the United States for medical purposes must pass minimum acceptable standards put forth ...
David A. Kessler is named commissioner of FDA. He is sworn in on the same day that the Nutrition Labeling and Education Act (NLEA) is signed. Kessler’s tenure is noted for its emphasis on tobacco r...
The Safe Medical Devices Act of 1990 requires hospitals and other user facilities to report deaths, serious illnesses, and injuries associated with the use of medical devices.
Joseph E. Murray and Dr. Edward Donnall Thomas win the Nobel Prize in Physiology or Medicine for work on organ and cell transplantation.
Virgin Altantic is first airline to carry an automated external defibrillator (AED), the Physio-Control Lifepak 500.
Although not the first space telescope, the Hubble is one of the largest and most versatile, and is well known as a vital research tool. Hubble is expected to function until 2014. One of Hubble's m...
FDA generic drug scandal widens amid pressure from Congress and consumer groups.
MD&DI predicts that in the 21st century, “the blind will see through microchip eyes hardwired to optic nerves; the brain will command intelligent prosthetic arms and legs using signals traveling al...
FDA approves the use of Minoxidil to treat baldness. The drug has previously been used to treat high-blood pressure. Video caption: The Minoxidil solution is sold under the brand name Rogaine in t...
MD&DI undergoes its first major redesign.
The Food and Drug Administration Act of 1988 officially establishes FDA as an agency of the Department of Health and Human Services. It also specifies that the president will appoint the commission...
FDA approves a five-minute screening test that is used to detect antibodies to the HIV virus in blood. The test uses a protein engineered by recombinant DNA technology. It is manufactured by Cambr...
Swiss-based Fischer Connectors introduced the first sealed connector 25 years ago followed by the introduction of the first hermetic connector.
FDA approves the drug AZT for treatment of HIV.
Congressman Henry Waxman (D–CA) holds a hearing to determine whether there is proper oversight of medical device approvals. He claims that Americans “continue to serve as guinea pigs for new medica...
Dr. Philippe Mouret performs the first laparoscopic cholecystectomy (gall bladder removal) surgery on a human in Lyon, France.
The director of the Office of Device Evaluation at CDRH, Kshitij Mohan, PhD, issues a memorandum on 510(k) policy that identified circumstances in which 510(k) would be a suitable clearance procedu...
The world’s worst nuclear power accident happens in Chernobyl when an engineering experiment goes wrong.
Space shuttle Challenger breaks apart 73 seconds after taking off from the Kennedy Space Center in Florida. All seven crew members are killed. The Challenger was the second shuttle built by NASA.
MD&DI launches its new Product Development section with “The Business Venture Approach to Planning New Products,” by Theodore Tyson. Photo courtesy of Damon Biotech
Although not approved by FDA until 1992, the first laser angioplasty is performed in 1985. NASA Jet Propulsion Laboratory originally developed the technology for satellite-based atmospheric studies...
Buckyballs are discovered by Harold Kroto, Robert Curl, and Richard Smalley. The discovery leads to the development of nanotubes, which are being used to develop nanosized medical devices. This mod...
The Bjork-Shiley heart valve is the first successful example of a mechanical prosthesis with a tilting disk design. However, its plano-convex design is prone to thrombosis, so it is updated with an...
MD&DI West conference and exposition debuts in Anaheim.
CDRH issues guidance on emergency use of unapproved devices and announces standards-setting policy for Class II devices.
FDA approves a blood test for AIDS that is then used to screen all blood donations in the United States.
William J. Schroeder becomes the first artificial heart patient to leave the hospital. He lives for 620 days.
Walter W. Fischer opened Fischer Connectors in Morges, Switzerland to design and manufacture high-performance connectors used in medical apparatus, scientific and instrumentation devices.
Color Doppler ultrasound systems enable hemodynamic assessments.
The first International Reports column appears in MD&DI.
Kary B. Mullis, PhD, develops the polymerase chain reaction (PCR), which allows a specific DNA sequence to be multiplied billions of times within hours. Mullis was later awarded the Nobel Prize in ...
The first conference and exposition sponsored by the magazine is held. More than 200 exhibitors present at this event in New York City.
President Reagan signs into law the Social Security Amendments, which establishes a new method of paying hospitals for Medicare inpatient services. The prospective payment system (PPS) is based on ...
To promote the research of rare diseases and the development of products intended to treat them, FDA passes the Orphan Drug Act in 1983. The law applies to diseases that affect fewer than 200,000 p...
Business Outlook column debuts with industry sales and marketing profile.
FDA approves the first recombinant-DNA drug product—biosynthetic human insulin. It is indistinguishable from pancreatic human insulin and virtually eliminates the use of porcine and bovine insulin ...
The Jarvik-7, the first permanent artificial heart, is implanted into patient Barney Clark, who lives for 112 days.
First story with “computers” in the title opens with an account of the company that purchased a computer for $18,000 and incurred $140,000 in programming costs. Photo courtesy of Merck & Co., Inc....
IBM introduces the first PC, with a starting price of $1565.
Although Cordis introduces first fully implantable neural stimulator in 1976, the company’s third-generation device, Model 900X—MK1, debuts in 1981. It offers more options of programmable parameter...
Carpentier-Edwards (now Edwards Lifesciences) begins a clinical investigation of its Perimount aortic pericardial bioprosthesis. Implantation of the device begins outside the United States.
Boston doctors implant artificial skin, made from shark cartilage, cowhide, and plastic, in patients with extensive burns.
Bruce Reitz, MD, performs the first successful heart-lung transplant at Stanford University Hospital.
Caption: Simona Zannetti (Medtronic) discusses the intricacies of conducting an IDE trial (Lecture given September 2008).
Click the link to read FDA’s advice on good manufacturing for devices.
Big-bang theory of universe proposed.
Packaging Forum and Legal Views columns introduced.
Novel lens designs initiate new era of intraocular implants; Extended wear contact lenses marketed.
Commissioner Donald Kennedy resigns; Jere Goyan named commissioner.
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