Three Democratic senators representing major high tech and medtech hubs in the United States are questioning the statutory basis of FDA’s new pilot program for digital health product precertification. “We support FDA’s efforts to update the medical device review regime to better accommodate digital health devices and believe that it is an important step in ensuring that […]
FDA to revamp medtech cybersecurity — with your help
FDA recently announced that it is taking additional steps to boost medtech cybersecurity, and it’s seeking outside help to do. The agency will soon release a new draft of its premarket guidance document to combat the growing threat of cyber attacks. In addition, the agency announced multiple partnerships with manufacturers, hospitals and more — as […]
FDA launches pilot to shorten some 510(k) approval times
The FDA has launched an interactive pilot program to streamline the 510(k) application for certain moderate-risk devices ranging from percutaneous catheters to lacrimal stents and intubation sets. The Quality in 510(k) “Quik” Review Program uses the agency’s eSubmitter software to format each submission and accepts 39 product codes for device types that it considers to be well-understood by the […]
What you should know about today’s top trends in medtech
Medtech’s hottest topics in M&A, intellectual property, finance and regulation will be on the agenda at DeviceTalks Boston Oct. 8-11. Patent attorney David Dykeman from the Boston office of the global law firm Greenberg Traurig will moderate the Oct. 9 hot topics panel in which the discussion will center around: · M&A trends from the perspective of […]
GI Dynamics raises $5 million for diabetes/obesity device
Investors have agreed to buy $5 million worth of GI Dynamics’ (ASX:GID) common stock, representing 6.9 million shares. The Lexington, Mass.-based company said it will use the money to fund the continued development of its EndoBarrier device and for general working capital. EndoBarrier is a plastic gut sleeve designed to treat type 2 diabetes and obesity […]
Heidelberg Engineering wins FDA nod for upgraded eye imaging technology
The FDA has approved Heidelberg Engineering’s optical coherence tomography angiography module (OCTA), the company said today. The module is available for new and existing Spectralis upgradeable diagnostic imaging devices used to manage diabetic retinopathy, age-related macular degeneration and other macular diseases. OCTA is a noninvasive imaging technique that provides three-dimensional visualization of perfused ocular vasculature. Structural OCT uses […]
FDA clears Olympus’ latest biopsy needle
Olympus said it has won FDA clearance for its EZ Shot Plus 25 G needle as well as an expanded indication for the EZ Shot 3 Plus product line for both fine needle aspiration (FNA) and fine needle biopsy (FNB). The approvals “can drive improved staging of disease and the potential to more easily connect patients […]
Avinger shareholders accept $5 million settlement
The plaintiffs in a class action suit against Avinger (NSDQ:AVGR) have approved the $5 million settlement that the company offered in March. Shareholders sued the company and several of its officers and directors claiming that they made false and misleading statements about Avinger’s original product, Pantheris, in its 2015 initial public offering. Avinger makes image-guided, catheter-based […]
Paradigm Spine wins coverage for spinal stenosis implant
BlueCross BlueShield of South Carolina has extended coverage to Paradigm Spine’s Coflex interlaminar stabilization implant, the company announced today. Approved by the FDA in 2012, Coflex is a non-fusion, motion-preserving stabilization implant for the treatment of lumbar spinal stenosis (LSS). Used in conjunction with a decompression procedure or in lieu of a spinal fusion, Coflex is a single-piece, […]
Cook, AcuityBio ink deal for lung cancer drug technology
Cook Biotech will collaborate with drug-delivery maker AcuityBio on Acuity’s lead lung cancer product, the companies said today. Acuity’s ABC103 will use Cook Biotech’s proprietary extracellular matrix (ECM) technology. ABC103 is a platform technology designed for localized, sustained drug delivery to prevent post-surgical lung cancer recurrence. It combines approved/ cleared surgical staple-line buttress, drug-eluting polymers and […]
FDA: Labeling requirements to add 2m hours to medtech industry’s regulatory burden
New FDA labeling regulations submitted to the FDA’s Office of Management and Budget are expected to add an additional approximate 1.6 million hours of work to record keepers at the agency and in the industry, according to an FDA notice. The added burden comes from changes to the federal watchdog’s medical device labeling regulations, which […]
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