Insightec seeks Parkinson’s indication in Japan for Exablate Neuro

Insightec said this week it submitted an application for pre-market approval to the Japanese Pharmaceuticals and Medical Devices Agency seeking an indication for its Exablate Neuro to treat advanced Parkinson’s Disease in patients suffering from mobility, rigidity or dyskinesia. The Israel-based company’s Exablate Neuro device uses high-intensity, focused ultrasound to thermally ablate targeted tissue, guided by continuous […]

InspireMD wins regulatory nod in Ecuador for CGuard, MGuard

InspireMD (NYSE:NSPR) said this week it won regulatory approval in Ecuador for its CGuard embolic prevention system and MGuard Prime devices. The approval comes shortly after the company inked an exclusive distribution agreement with Ecuadorian medical device distributor Cardiobene, Israel-based InspireMD said. Both companies have worked together to secure regulatory approvals in the country, InspireMD added. “We […]

Medtech Association to host inaugural MedTechIDEAS Summit

The Medtech Association is hosting its inaugural MedTechIDEAS Summit on May 31 in Skaneateles Falls, N.Y. The event will take place at 11 a.m. until 5:30 p.m. at the Lodge at Welch Allyn. The MedTechIDEAS Summit is a quarterly conference series that presents a “big idea” in healthcare from an industry thought leaders while delivering competence-focused […]

PavMed subsidiary Lucid Dx inks licensing deal with Case Western Univ.

Pavmed (NSDQ:PAVM) subsidiary Lucid Diagnostics said today it finalized a licensing agreement with Case Western Reserve University to commercialize its EsoCheck non-invasive cell sampling device and DNA biomarker test. The New York-based company said that the EsoCheck device has been shown to effectively and accurately detect Barrett’s Esophagus, which is a precursor to the most common […]

Med-El wins FDA nod for Rondo 2 cochlear implant audio processor

Cochlear implant maker Med-El USA said today it won FDA approval for its Rondo 2 cochlear implant audio processor with an expected launch of the device this fall. The Durham, N.C.-based ocmpany said the newly cleared Rondo 2 audio processor features wireless charging capabilities that allow the device to fully recharge in four hours after being […]

Here’s how Sanofi separates true innovation from all the hype in digital health

Recognizing that digital technology is here to stay in the business of healthcare, pharmaceutical companies have not shied away from collaborating with the folks in Silicon Valley. Sanofi (NYSE:SNY), for instance, has dove in feet first, striking deals with major tech players like Verily. But weeding out true disruptions from all the noise isn’t easy. “There’s […]

Teleflex’s NeoTract wins AUA support for UroLift system as standard-of-care

Teleflex (NYSE:TFX) subsidiary NeoTract said today that the American Urological Association now recommends the use of NeoTract’s UroLift system as a standard of care treatment for lower urinary tract symptoms due to benign prostatic hyperplasia. The company’s UroLift system uses tiny devices inserted into the urethra in a minimally invasive procedure to reopen the lower urinary tract by pushing aside […]

DHS warns of cybersecurity weakness in Medtronic N’Vision neurostim programmer

The Department of Homeland Security this week released a report warning of cybersecurity vulnerabilities in Medtronic‘s (NYSE:MDT) N’Vision clinician programmer designed for use with neurostimulation devices that could allow outside agents to access personal health data. The DHS said that the vulnerability was originally reported by Whitescope LLC, and requires an individual gain physical access to […]

Report: FDA exempts surgical facemasks from 510(k) requirements

The FDA finalized a rule this week exempting specific disposable respiratory protective masks from 510(k) requirements, according to a Regulatory Affairs Professionals Society report. The move was adopted in hopes of reducing regulatory burden on manufacturers of the surgical apparel devices and to eliminate the costs associated with regulatory clearance, according to the report. With […]

Valeritas touts new data for insulin delivery device

Valeritas (NSDQ:VLRX) touted data today from two new studies of its V-Go wearable insulin delivery device in patients with Type II diabetes. In one three-month evaluation of 60 people with Type II diabetes, researchers assessed if using V-Go could improve glycemic control in patients who were uncontrolled on prior treatment regimens. Get the full story at […]