A proposed guidance to expedite the acceptance process for the 510(k) program at the U.S. Food and Drug Administration would require the agency to respond in 15 days to an applicant. In that period, FDA reviewers would look at whether the application is complete from an administrative point of view. The goal is to ensure […]
Stryker announced Monday that the U.S. Food and Drug Administration has cleared a clot removal device to treat patients experiencing acute ischemic stroke. Ischemic strokes are caused by blocked arteries and constitute the overwhelming majority of strokes, according to the Mayo Clinic. The Trevo Pro Retrieval System performed better than Merci Retrieval, made by Concentric […]
In a recent interview, Esperion president and CEO, Sheldon Koenig talks about the reality of statin intolerance and his company’s expansion into new diseases
Codman & Shurtleff Inc., part of the Depuy Synthes companies, announced Tuesday that it has received a premarket approval from the U.S. Food and Drug Administration to market a neuromodulation product that treats spasticity. The MedStream Programmable Infusion System is an implanted device that can deliver antispasm drug baclofen directly into the spinal canal through […]
Sunshine Heart (NASDAQ Capital Markets: SSH), which makes a an implantable, non-blood contacting, cardiac assist device to treat moderate to severe heart failure, has received conditional approval from the U.S. Food and Drug Administration for a component of that device. The public company, which has been the recipient of a huge amount of interest from investors […]
A California medical device company announced Monday that the U.S. Food and Drug Administration has cleared more sizes of the world’s only torqueable balloon catheter used to treat complex percutaneous coronary interventions. TriReme Medical, based in Pleasanton, said the Glider PTCA balloon catheter is now approved for the treatment of coronary lesions in balloon diameters […]
A long-running complaint from the device industry has been that the U.S. Food and Drug Administration is slow and opaque in how it reviews and communicates with companies developing new products. On Thursday, the agency issued draft guidance on a new program that appears to show that it has taken the criticism to heart (and […]
Across the nation, state-based health insurance exchanges are searching for ways to better serve their communities while making enrollment easier, more personal, and more accessible for everyone.
The U.S. Food and Drug Administration announced Monday that it has approved the first-of-its kind glaucoma stent to be used during cataract surgery to prevent intraocular pressure. The iStent made by Glaukos Corp., a California medical device firm, is a titanium tube that can help drain excess fluid that builds up pressure inside the eye. […]
Late Wednesday, a U.S. Food and Drug Administration panel recommended that Edwards Lifesciences (NYSE:EV) transcatheter aortic valve replacement procedure be approved for patients with high risk to the alternative open-heart surgery. Late last year, Edwards became the first company in the U.S. to win FDA approval for using the so-called TAVR procedure on patients with […]
Arteriocyte Medical Systems has received U.S. Food and Drug Administration approval for a product associated with its Magellan stem cell harvesting medical device. The latest FDA approval for the Cleveland-based company concerns an anticoagulant solution used in the device, which harvests and quickly concentrates stem cells and blood platelets during surgeries. These concentrated cells can […]
An epidural catheter from medical device company Teleflex (NYSE:TFX) has received 51o(k) clearance from the U.S. Food and Drug Administration. The Arrow FlexTip Plus Closed Tip, Multi-Port epidural catheter is an expansion of the company’s Arrow FlexTip Plus catheter, according to a company statement. The FlexTip Plus design is aimed at significantly reducing complications commonly […]
In a landscape where complexity has long been the norm, the power of one lies not just in unification, but in intelligence and automation.
A fecal incontinence test has won regulatory approval, announced the company that originally licensed the technology from the Mayo Clinic in 2009. Medspira, based in Minneapolis, said the U.S. Food and Drug Administration has approved its mcompass anorectal manometry device that can evaluate how the pelvic floor of a person with constipation or fecal incontinence functions. […]
The U.S. Food and Drug Administration has approved a new, smaller implantable cardioverter defibrillator made by St. Jude Medical (NYSE:STJ), the medical device maker announced Wednesday. The announcement comes less than a month after the device maker said that European regulators had given the nod to the same device — the Ellipse ICD. The Ellipse […]
Less than a week after making a regulatory submission for a $1 million capital raise, prostate health company ProUroCare Medical, based in Eden Prairie, Minnesota, announced that it has secured market clearance for its diagnostic device. ProUroCare has developed an elasticity imaging technology that can be used to document abnormalities of the prostate. The technology would […]
A magnetic resonance imaging coil specialized for imaging of the infant brain, spine, heart and torso has received 510(k) clearance from the U.S. Food and Drug Administration. Cleveland-based Sree Medical Systems‘ obtained 510(k) clearance of its Infant Array, a receive-only radio-frequency coil array, in March, according to the FDA’s website. Sree’s new product is intended […]
Disruptive, fast prototyping, iterative, warp speed. These are not words people typically associate with the U.S. Food and Drug Administration's medical device review process. But in a media briefing on Monday, those words were bandied about liberally and signaled that federal bureaucrats are attempting to embrace a culture of innovation in their effort to help companies commercialize novel, safe products more quickly than before.