Insightec said this week that the FDA approved an expansion for the Exablate Neuro device to include the treatment of patients with tremor-dominant Parkinson’s disease. The company’s device uses focused ultrasound to perform an incision-less thalamotomy, guided by MR imaging. The Exablate Neuro was previously only approved for medication-refractory essential tremor. “This is another validation […]
Regulatory/Compliance
FDA | Recalls | 510(k) | Pre-Market Approvals | MDSAP | Clinical Trials
Cardiva Medical wins FDA PMA for Vascade MVP vascular closure device
Cardiva Medical said today it won FDA premarket approval for its Vascade MVP venous vascular closure device. The Vascade MVP system is composed of a thrombogenic bioabsorbable collagen patch and a collapsible mesh disc, the Santa Clara, Calif.-based company said. The device functions by placing a collapsible mesh disc against the inner vessel wall to stop […]
FDA previews safety-focused STeP pathway, finalizes breakthrough device guidance
The FDA today outlined its plans for finalizing guidance on its Breakthrough Device Program as well as plans for a new Safer Technologies Program (STeP) intended to encourage device tech that significantly improves safety as compared to current devices on the market. In a new FDA release, Commissioner Dr. Scott Gottlieb said that since its […]
Medical device industry regulation is changing: What you need to know
The medical device industry has been taking a lot of heat lately when it comes to patient safety. There’s the recent International Consortium of Investigative Journalists’ “Implant Files” report, as well as the documentary “Bleeding Edge” on Netflix. Both paint a picture of lax medical device regulation resulting in patients exposed to poorly tested implants. Veteran regulatory […]
FDA clears EhmetDX’s 3D CBCT positioning software
Early stage medical equipment developer EhmetDX said late last week that it won FDA 510(k) clearance for its 3D CBCT positioning software. The Plymouth, Mich.-based company said that the newly cleared system is designed to guide the position of proton beams in patient treatments. The system is slated to be used in patient treatment at […]
FDA opts not to change device class definitions
The medtech industry appears to have won a round in the regulatory arena. The FDA issued a final rule amending its regulations on classifying and reclassifying medical devices under the Food and Drug Administration Safety and Innovation Act (FDASIA), passed in 2012. Published today in the Federal Register, the rule says it “provides for the […]
Pear Therapeutics wins FDA nod for digital opioid addiction treatment app
Pear Therapeutics has received FDA 510(k) clearance for its reSET-O medical application that helps treat patients who have an opioid use disorder. The reSET-O app is a prescription cognitive behavioral therapy that is designed to be used with outpatient treatment and under the care of a healthcare professional. It is also designed to be used […]
Aortica touts FDA clearance to use Medtronic’s Valiant Navion in AAA IDE study
Aortica said today that the FDA approved the use of Medtronic‘s (NYSE:MDT) Valiant Navion stent graft system alongside Aortica’s AortaFit in a physician sponsored IDE study. The study, being run by principal investigator Dr. Benjamin Starnes at the University of Washington, will now use the Valiant Navion as a platform for fenestrated endovascular repair together with […]
Medtronic wins FDA nod for InterStim sacral neuromod programmer
Medtronic (NYSE:MDT) said today that the FDA approved its InterStim smart programmer, designed to work with the company’s InterStim sacral neurmodulation system intended for tor treating overactive bladder, chronic fecal incontinence and non-obstructive urinary retention. The newly cleared smart programmer is run on a Samsung Electronics (LON:BC94) mobile device and allows clinicians to personalize patient care and manage […]
FDA: GE R860 ventilator safety guard recall is Class I
The FDA today labeled a select recall of GE Healthcare‘s (NYSE:GE) CareScape R860 inspiratory safety guards, designed for use with a ventilator, as Class I. Class I designations, the FDA’s most severe classification, are used when there is a reasonable probability that product use could cause serious adverse health consequences or death. The R860 inspiratory safety […]
Check-Cap wins conditional IDE approval for C-Scan pilot study
Check-Cap (NSDQ:CHEK) said today it won conditional approval from the FDA for its investigational device exemption application to launch a pilot study of its C-Scan system. The Israel-based company’s C-Scan system is designed as an alternative to standard colon cancer screening methods. The system uses an ingestible, ultra-low dose X-ray capsule and a wireless tracking system […]