No, hyperbaric oxygen therapy (HBOT) has not been clinically proven to cure or be effective in the treatment of cancer, autism, or diabetes. But do a quick search on the Internet, and you'll see all kinds of claims for these and other diseases for which the device has not been cleared or approved by FDA.
Regulations for the Restriction of Hazardous Substances (RoHS) 2 impact the ways in which companies do business, especially in the medical device industry. On July 22, 2014, when a company places a CE mark on medical devices, they are confirming all appropriate measures were taken to ensure each product meets the RoHS 2 directive...
Covidien recalled some lots of its Monoject syringes after discovering a sterilization mishap and labeling problem. The issues affected 14 lots in shipments that went out to customers in the U.S. and Bermuda, the Mansfield, Mass.-based medical products giant said.
Medical device makers issued more than 400 recalls during Q2, 30% more than in the previous quarter. That's higher than reported for the last 5 quarter, according to a report by Stericycle ExpertRECALL. The recalls affected about 9.2 million units, a 50% decrease in the quantity of products affected in Q1.
An Idaho-based company that plans to build a facility in southeastern New Mexico to make uranium waste safe for long-term disposal has put its plans on hold because of a funding shortage.
The FDA is shifting some of its wound care review responsibilities away from the Center for Devices & Radiological Health, handing them instead to the Center for Biologics Evaluation & Research. Some of the products transfered include the Apligraf diabetic foot and venous leg ulcer treatment from Organogenesis.
The Healthcare Solutions experts at BSI, a leading Notified Body that helps companies comply with the essential regulatory requirements of the European Union, are offering members of the medical device community exclusive access to global industry experts at three Roadshow events in key U.S. cities in September.
It was discovered that there was a potential for the piercing pin on certain ISO-compliant Hospira blood sets to puncture the outer wall of the non-ISO-compliant blood bags during insertion of the pin into the blood bag. This can lead to the leakage of blood and health care provider exposure to blood products.
Kirk Barker, electronic product manager at maxon motors, was a part of the staff written article, “Portability Is the Name of the Game.” He took time to present a full array of responses that were not able to be included in the article, so they are presented here.
Cardica and its distribution partner Century Medical are shooting for Japanese regulatory approval for the stapling cartridge components of Cardica's MicroCutter Xchange surgical device. Redwood City, Calif.-based Cardica sent in the cartridge design validation application to Japan's Pharmaceuticals & Medical Devices Agency today.
Alere Connect has been granted a 510(k) market clearance by the U.S. Food and Drug Administration for the Alere MobileLink. The new product offering is one of Alere's connected device technologies designed to empower patients by allowing self-testing at home and delivering data quickly and seamlessly to clinical systems accessed by their healthcare providers.
Meeting Notice: September 11-12, 2013 Circulatory System Devices Panel of the Medical Devices Advisory CommitteeAugust 13, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
On September 11, 2013, during session I, the committee will discuss and make recommendations regarding the proposed classification of external cardiac compressor (ECC) devices, one of the remaining preamendments class III devices regulated under the section 510(k) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) (21 U.S.C. 360(k)) (510(k)) pathway.
Ensuring compliance with IEC 60601-1 is simply a must for every medical device manufacturer. However, with revisions and updates, it’s difficult for a company to ensure they are constantly in compliance unless they have a dedicated expert on staff. Therefore, an excellent solution for this challenge is to partner with a company that is exactly that—an expert on the standard.
The U.S. Food and Drug Administration has awarded a $5.6 million contract to Harvard University’s Wyss Institute for Biologically Inspired Engineering to apply its breakthrough organs-on-chips technology to assess medical countermeasures for treating acute radiation syndrome (ARS), also known as radiation sickness.
Cardica, Inc. and Century Medical, Inc. today announced that Century Medical filed for regulatory approval of Cardica's MicroCutter XCHANGE™ 30 cutting and stapling cartridge in Japan. The submission to the Pharmaceuticals and Medical Devices Agency (PMDA) includes design, validation and verification data for the MicroCutter XCHANGE 30 cartridges.
Austin, Tex.-based LDR landed its 1st FDA approval for its Mobi-C device, a cervical disc replacement for patients with degenerative disc disease. The privately held company, which was founded in France but is headquartered in Texas, is marketing the product as better alternative to a last-resort procedure called anterior cervical discectomy fusion, which fuses the vertebra to ease painful symptoms of a herniated disk.
Improving patient access to new medical devices by strengthening and streamlining the clinical trial enterprise is a priority for CDRH. An important part of reaching that goal is to better track milestones in clinical trial development, Investigational Device Exemption (IDE) approval, study initiation, and study completion.
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis. A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA.
Verizon announced today that it has received U.S. Food and Drug Administration 510(k) clearance for Converged Health Management, a cloud-based, remote patient-monitoring medical device. This marks the first time Verizon has sought and gained FDA clearance for a healthcare solution.
The U.S. Food and Drug Administration today approved the first rapid Human Immunodeficiency Virus (HIV) test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous or fingerstick whole blood specimens.
The recall last March of Johnson & Johnson unit Cordis Corp.'s Optease vena cava filter is Class I, according to the FDA, meaning the device could cause serious injury or death. Cordis notified healthcare providers March 29 about 33,000 Optease devices, on concerns that they could be implanted backwards, according to the FDA.
The Optease Retrievable Vena Cava Filter is used for the prevention of recurrent pulmonary embolism in patients under specific situations. The device is implanted into the inferior vena cava and is designed to be retrieved when the patient no longer requires a filter.
Presentations posted for Battery-Powered Medical Devices Workshop: Challenges and Opportunities, July 30-31, 2013August 8, 2013 12:00 am | by U.S. Food & Drug Administration | News | Comments
Batteries play a significant role in the overall safety, performance, and reliability of many life-saving and life-sustaining medical devices. As more medical devices become computerized, compact, and mobile, the number of battery-powered medical...
Medical device makers would do well to fortify their cybersecurity strategies in preparation for the extra layers of software testing and review in development at the FDA. Federal healthcare regulators have solicited bids from security group Codenomicon Defensics to help build a "cybersecurity laboratory" where regulators can take a closer look at software bugs and weaknesses in medtech systems.
In Part 1 of this blog, I described the background and approaches StarFish Medical employed for more modern devices with a comprehensive technical file, giving five top tips. In Part 2, I now describe how we recertified for older devices where the available design documentation was less comprehensive.