RefleXion Medical announced today that the FDA cleared its Scintix biology-guided radiotherapy treatment for cancer. Hayward, California-based RefleXion designed the Scintix platform for use in treating both early- and late-stage cancers. The company said Scintix is the first and only radiotherapy that allows each cancer’s unique biology to autonomously determine how much radiation to deliver. […]
FDA
FDA approves fourth-gen rechargeable sacral neuromod tech from Axonics
Axonics (Nasdaq:AXNX) announced today that the FDA approved its fourth-generation R20 rechargeable sacral neuromodulation system. The implantable system provides therapy for patients suffering from overactive bladder or fecal incontinence. The approval indicates the Axonics R20 for a functional life in the body of at least 20 years. It also reduces the frequency with which a […]
FDA approves Abbott’s spinal cord stimulation system for diabetic peripheral neuropathy
Abbott (NYSE:ABT) announced today that the FDA approved its spinal cord stimulation system for treating painful diabetic peripheral neuropathy (DPN). The Proclaim XR SCS system offers relief to patients with DPN, a debilitating complication of diabetes. These patients need alternatives to traditional treatment approaches like oral medication. Users of Proclaim XR can also use Abbott’s […]
FDA expands access to BioVentrix ischemic heart failure treatment
BioVentrix announced today that it received FDA approval for its application for an expanded access program for the Revivent TC system. San Ramon, California-based BioVentrix designed the Revivent TC system to support a minimally invasive heart procedure. It treats a dilated left ventricle of patients with ischemic heart failure. They also have reduced ejection fraction […]
FDA clears new sepsis diagnostic from Cytovale
Cytovale announced today that it received FDA 510(k) clearance for its IntelliSep test for the early detection of sepsis. San Francisco-based Cytovale designed IntelliSep to provide test results in under 10 minutes. The emergency department-focused tool helps clinicians recognize sepsis and make time-sensitive critical decisions. It provides actionable answers directly from a standard blood draw. […]
FDA clears intervertebral body fusion system from VySpine
VySpine announced today that it received FDA 510(k) clearance for its LumiVy NanoVy TI lumbar intervertebral body fusion (IBF) system. Tallahassee, Florida–based VySpine designed the system for IBF at either one level or two contiguous levels in the lumbar spine. It goes between L2 to S1 for the treatment of degenerative disc disease (DDD) with […]
Titan Medical meets with strategic buyers and investors as surgical robot developer considers its future
Titan Medical (Nasdaq:TMDI) met with potential buyers of the surgical robotics company this week in San Francisco. The Toronto-based medical device developer has been considering the best options for investors and the company’s Enos surgical robot. Facing delisting of its stock from the Nasdaq exchange due to its low price last year, Titan Medical announced […]
FDA hits Olympus with warning letters after factory inspections
The FDA today released warning letters against Olympus Medical Systems Corp. and Olympus Corp. subsidiary Aizu Olympus following inspections of their endoscope and reprocessor manufacturing facilities. The warning letters allege medical device reporting (MDR) and quality system violations at the manufacturing operations. “Olympus’ highest priority is providing patients and users with safe and effective medical […]
FDA clears Lightning Flash thrombectomy system from Penumbra
Penumbra (NYSE:PEN) announced today that it received FDA clearance for the Lightning Flash mechanical thrombectomy system. Alameda, California-based Penumbra also initiated the launch for the system. The company called Lightning Flash “the most advanced and powerful mechanical thrombectomy system on the market.” Lightning Flash features the company’s novel Lightning intelligent aspiration technology with dual-clot detection […]
MedAlliance picks up FDA IDE nod for drug-eluting balloon
MedAlliance announced today that its novel sirolimus-eluting balloon received conditional FDA investigational device exemption (IDE). Geneva, Switzerland-based MedAlliance can now initiate its pivotal clinical trial for the treatment of coronary de novo lesions. Get the full story at our sister site, Drug Delivery Business News.
FDA approves next-gen inhaled nitric oxide delivery system from Vero Biotech
Vero Biotech announced that it received FDA approval for its latest-generation tankless inhaled nitric oxide (iNO) delivery system. Atlanta-based Vero Biotech developed its third-generation Genosyl delivery system for respiratory therapists. Its new features include faster dosing, simpler workflow and operational efficiency. Get the full story at our sister site, Drug Delivery Business News.