FDA's San Francisco District and AdvaMed have announced a public workshop on device regulations, geared toward assisting small and start-up manufacturers. It will be held July 12-13 in Fremont, CA. Too many firms, big and small, seem to have trouble completing flawless applications and following every step of the QSR. Events like this can be a big help. An online registration form is available.
Polymer science may not be a discipline expected to help in the fight against the spread of avian influenza and other communicable diseases, but it is. The Hartford (CT) Courant reports that Ahlstrom Corp. (a Finnish company whose U.S. operations are based in Windsor Locks, CT) has created a breathable viral barrier that is being used in surgical gowns, masks, and related protective clothing. It can block the spread of anything .027 microns or larger.
CDRH has been busy getting inspection-related guidance documents ready. Last week it published the latest version of its general guidance document on inspections of medical device manufacturers. Today it published a draft guidance intended to help manufacturers prepare for FDA review of the manufacturing section of their PMAs, which includes an inspection.
Acting FDA Commissioner Andrew von Eschenbach says all the right things. At last week's annual meeting of the Medical Device Manufacturers Association , he made some sweeping and impressive statements about the agency's place in the upcoming healthcare technology revolution. Among his pronouncements: "We can go further. The challenge is to not just be [a science-based regulatory agency], but to be a science-and-technology-led... agency that can illuminate the pathway forward.
The Houston Chronicle reports that ECardio Diagnostics LLC has launched its eTrigger AF920 event monitor for detection of atrial fibrillation among asymptomatic patients. Unlike standard cardiac monitoring devices, this monitor automatically detects and records asymptomatic events without the patient having to activate it.
Medtronic has received reimbursement approval in France for its Endeavor drug-eluting coronary stent system. The stent is now available in all Western European markets. Last month, Medtronic presented clinical data at the Paris Course on Revascularization that demonstrated the long-term safety and efficacy of the Endeavor. Three- and two-year studies produced low rates of repeat procedures and major adverse clinical events.
Judges are continuing to obtain more power over intellectual-property decisions affecting devices and other industries, MD&M East attendees learned last week. The U.S. Supreme Court recently ruled, in a case against eBay, that judges do not have to grant a permanent injunction to stop infringement even after finding a party guilty of it. All they are required to do is to make the party pay fees and damages to the patent holder, said patent attorney Steven J. Grossman, partner at Grossman, Tucker, Perreault & Pfleger, PLLC (Manchester, NH).
The New York Times and Reuters News report that the board of Cyberonics, Inc. approved stock option grants for three executives just hours after the company received positive regulatory news in June 2004. The next morning, the company's shares posted huge gains. The timing came to light when Amit Hazan, a device industry analyst for SunTrust Robinson Humphrey, noted it in an investor advisory.
The Boston Globe reports that more uninsured and underinsured Americans are flying to countries like India and Thailand to have surgery because surgical costs in the United States are so high. Some employers are even encouraging it, since the quality of care in those countries is high and the cost is substantially lower. This is yet another reason why U.S.
Citing the lack of uniformity in the size of medical devices and their packaging, FDA a few years ago decided not to require devices to be bar-coded or otherwise uniformly identified, as it did for pharmaceuticals. That may change after the release of a report the agency commissioned from Eastern Research Group (Lexington, MA). The report catalogs the benefits of a unique device identification system and suggests the time may have come to implement one.
Fujirebio Diagnostics, Inc. (Exton, PA), a leader in cancer diagnostics, announced it has bought rival CanAg Diagnostics AB (Gothenburg, Sweden). Both companies are known for their serum tumor markers. Combining the R&D efforts of both firms could enhance the development of new cancer assays, which are always needed.
The device world and the high-tech world have collaborated onÂ a portable system that programs pacemakers and implantable cardioverter-defibrillators .Â St. Jude Medical and IBM have launched the Medical Merlin Patient Care System, which helps clinicians conduct tests, analyze data, and better program implanted devices. It is a portable computer with a touch screen that allows doctors to retrieve data and make programming changes quickly while making visits to patients.
Kensey Nash Corp. (Exton, PA), best known for developing the Angio-Seal and licensing it to St. Jude Medical, is buying, not selling, for once. In a release published on devicelink.com , the cardiovascular devices and biomaterials maker announced it has acquired IntraLuminal Therapeutics, Inc. (ILT; Carlsbad, CA) for $8 million.
Earlier this week, CDRH announced it will pursue an optional MDUFMA goal regarding 510(k)s but not one regarding PMAs. For fiscal year 2007, it aims to render a final decision for 80% of 510(k) applications within 90 days. It declined to set a goal of a final decision for 50% of PMA applicaitons within 180 days. AdvaMed and the Medical Device Manufacturers Association gave the news a lukewarm response. The docket for comments is open for about another month. Information about filing comments is available here .
In recent years, device therapies have emerged in some treatment areas that had been the exclusive province of drug therapies. The latest is moderate to severe asthma. The Associated Press has a report on a new procedure called bronchial thermoplasty, which uses an ablation device to burn off lung tissue that is blocking the patient's ability to breathe. The therapy is too new for its long-term effects to be known, but doctors seem enthusiastic about it.