Study: Doctors receiving high compensation fail to disclose relationships with med device firms

Doctors aren’t accurately reporting compensation they receive from medical device companies, according to a new study published in the JAMA Surgery. In the study, researchers performed a bibliometric analysis of the 100 physicians receiving the highest compensation from 10 large surgical and medical device manufacturers using payment data from the Centers for Medicare & Medicaid

Medical devices: The transition to connected devices

C&K Cutting Edge Blog #2 By Roger Bohannan – C&K Medical Segment Leader The shift in medical device development from the unconnected device to the connected device is upon us. This shift will make an enormous impact on the quality and effectiveness of medical care over the next decade and beyond.  Device design engineers worldwide

ValenTx raises $10.3 million for implantable gastric bypass device

Startup ValenTx has attracted nearly $10.3 million from 32 investors, according to a filing with the Securities & Exchange Commission. The Maple Grove, Minn. company is developing a removable gastric bypass device as an alternative to Roux-en-Y gastric bypass surgery. It raised $10,271,050 in the round begun July 18, 2018. The ValenTx endoluminal bypass therapy

GW Plastic wins Vermont Business Growth Award and workforce development grants

GW Plastics recently announced that it has won the 2018 Vermont Business Growth Award, as well as two workforce development training grants. The annual Vermont Business Growth Award is presented by the Vermont Business Magazine and KeyBank and acknowledges the top Vermont businesses that have had the greatest growth over the last five years. This

FDA clears CoreLink’s new spinal implant

Spinal implant maker CoreLink has landed FDA 510(k) clearance for a new anterior lumbar (ALIF) interbody device. The Foundation 3D ALIF uses the company’s proprietary mimetic metal technology, which mimics natural bone characteristics, including 100% open-pore architecture and micro-roughened porosity with hydro-wicking properties. The new ALIF design also has patent-pending technology that creates a combination of

Syneo receives patent in China

Syneo recently received a patent in China for its Servo Electric Press Two-Stage Force technology. The patent gives the company the rights to use its two-stage force measuring system in manual electric press and automatic electric press (press-fit) machine applications. The patent protects the company’s technology that is featured in the two-stage force measuring system

FDA approves first generic Epipen

The FDA this week approved the first generic version of Mylan‘s (NSDQ:MYL) Epipen emergency allergy auto-injector. Teva Pharmaceuticals (NYSE:TEVA), which won the historic approval, plans to market the generic epinephrine auto-injector in 0.3mg and 0.15mg doses. There are other epinephrine auto-injectors on the market in the U.S., but Teva’s is the first that’s approved to directly substitute

FDA finalizes streamlined bundled, quarterly MDR reporting system

The FDA today announced it finalized its new Voluntary Malfunction Summary Reporting Program intended to streamline medical device manufacturer malfunction reporting. The program was created in part through public comments received by the FDA and is intended to allow manufacturers to report “certain device malfunctions in summary form on a quarterly basis” instead of an

SPR Therapeutics’ new PNS system wins FDA nod

The FDA has approved SPR Therapeutics’ (Cleveland) Sprint endura (single lead) and extensa (dual lead) peripheral nerve stimulation (PNS) systems. The minimally invasive Sprint system is the only FDA-approved percutaneous PNS system that is indicated for up to 60 days in the back and/or extremities for both chronic and acute pain and is the industry’s only

Report: FDA’s Gottlieb says pediatric device approvals are lagging

FDA head Scott Gottlieb said that over the past 10 years there have been “far too few” devices hitting the US market designed specifically for a pediatric population, according to a recently posted Regulatory Affairs Professionals report. The statement came at a two-day FDA workshop this week, according to the report.   Read the whole story on

Avinger posts loss on disappointing sales

Avinger (NSDQ:AVGR) today posted a second-quarter losses-per-share that missed an analyst’s expectation, sending its share price down on Wall Street despite nearly halving its losses. The Redwood City, Calif.-based medical device maker reported losses of -$6.6 million, or -98¢ per share, on sales of $2.1 million for the three months ended June 30, 2018. That compares with

BARDA, J&J launch ‘reimagined’ emergency respiratory device challenge

The Dept. of Health and Human Services’ Biomedical Advanced Research and Development Authority and Johnson & Johnson‘s (NYSE:JNJ) Janssen R&D are launching a new crowdsourced tech development challenge looking to support innovative respiratory protection devices, according to a recently listed government posting. The new contest, dubbed the QuickFire Challenge, will look to award up to

“Snake oil” BP app got high user marks despite inaccurate results

People may like mobile blood pressure apps better when the apps reveal positive results, even if those results are inaccurate 80% of the time, according to a recent study. A team of researchers who previously revealed the inaccuracy of the Instant Blood Pressure (IBP) app returned to the topic to study 81 adults who compared the

Study slams FDA’s ‘fast-track’ approval process

More than 98% of the 161 foot and ankle devices that were recalled from 2007 through 2017 were approved through the FDA’s 510(k) process, according to a new study. That left one recalled device approved via the more stringent premarket approval (PMA) process and two for which the submission procedure was not indicated. The 510(k) process

SpaceLabs’ Arkon anesthesia system recalled again

The FDA  has slapped SpaceLabs Healthcare with a Class 1 recall of its Arkon anesthesia delivery system for going into a “failed state” on numerous occasions since 2013. The recall covers 253 units. No injuries or deaths were reported. During the failed state, the mechanical ventilation function stops working while the machine is in use