Ambio Health, a Stamford, Conn.-based company that specializes in health monitoring, received a Class II FDA 510(k) clearance for its Ambio Remote Health Monitoring System. With the intent of saving patients money, the device, which includes a wireless blood glucose monitor and wireless gateway (a blood pressure meter and weight scale, also FDA-approved, can be […]
The FDA may be freed up to put its user fees to use for product review for medical devices and drugs, if a bipartisan bill introduced in the House passes. In essence, the bill exempts the FDA user fees from sequestration and may take one burden off the already slow approval process. That adds up […]
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.
It’s easy to get excited when really intriguing and previously unthinkable technology reaches the marketplace. For example, there’s been a lot of hype in the news leading up to the U.S. Food and Drug Administration’s announcement today that it approved Second Sight Medical’s Argus II Retinal Prosthesis system — the world’s first bionic eye. The […]
Minnesota orthopaedics device startup Conventus Orthopaedics announced Monday that the U.S. Food and Drug Administration has approved its minimally invasive treatment for repairing wrist fractures. The Conventus Distal Radius Surgical System is a self-expanding implant that requires small incisions and is able to reduce “surgical trauma by as much as 80 percent compared to traditional […]
Dune Medical Devices announced Monday that the company has received a letter from the Food and Drug Administration indicating that it is close to receiving a pre-market approval from the agency. The FDA informed Dune Medical, which has filed a PMA for its breast cancer detection device during surgeries, that it will grant the approval […]
The Food and Drug Administration has cleared an ultrasound bladder scanner made by Norwegian firm Vitacon AS to diagnose bladder dysfunction and the firm has signed a marketing agreement that will launch the product in the U.S. The VitaScan LT USB Scanner is an alternative to measuring bladder volume using urethral catheters, the company said […]
In a landscape where complexity has long been the norm, the power of one lies not just in unification, but in intelligence and automation.
Halt Medical, a medical device company based in Brentwood, California, announced Tuesday that the Food and Drug Administration has cleared its Acessa device that gynecologists can use to treat female uterine fibroids. The device uses RF ablation to treat just the fibroids and is an alternative to traditional fibroid surgery where “layers of healthy tissue […]
Salt Lake City, Utah-based Amedica announced Thursday that it has received regulatory clearance for the second generation of an interbody fusion device system. The U.S. Food and Drug Administration has cleared its cervical and lumbar interbody fusion devices (IBF) made with a proprietary biomaterial. These devices and their design improvements will help surgeons perform minimally invasive […]
Roche Diagnostics Corp. announced Tuesday that the company has received clearance from the Food and Drug Administration to market two automated tests for herpes simplex virus 1 and 2. The tests are meant to be used to diagnose such infections in people who are sexually active and on expectant mothers. The clearance is specifically for […]
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 […]
How can AI benefit and improve patient outcome in the emergency department? Watch the latest episode to find out.
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. […]
With the ever-increasing stringency, time, and expense associated with FDA approval for medical devices, debate is sharpening in the medical devices industry over whether it is actually better business strategy to prioritize getting a CE mark for your product. This article gives an overview of a recent iteration of a robust debate within the Medical […]