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 […]
Munck Wilson Mandala Partner Greg Howison shared his perspective on some of the legal ramifications around AI, IP, connected devices and the data they generate, in response to emailed questions.
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 […]
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 […]
At the Abarca Forward conference earlier this year, George Van Antwerp, managing director at Deloitte, discussed how social determinants of health and a personalized member experience can improve medication adherence and health outcomes.
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 […]
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 […]
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.