News

DOJ subpoenas Fuji, Pentax about dirty duodenoscopes

The U.S. Department of Justice has subpoenaed two additional duodenoscope makers--Fujifilm Holdings and Pentax Medical--Reuters reported.

St. Jude gains CE mark for first app-based pain neuromodulation patient trial system for use ahead of implant

Major medical device makers haven't exactly rushed to integrate smartphones and tablets into their product lineups, despite their ubiquity and obvious potential medical utility. But now St. Jude Medical has gained a CE mark and launched the first app-based, wireless system for use during an initial patient trial period with an external neuromodulation chronic pain treatment device prior to receiving a permanent implant.

FDA says Baxter Vascu-Guard peripheral vascular reconstruction patch can cause fatal surgical errors

Baxter has recalled a patch used in peripheral vascular reconstruction surgeries. The move to recall almost 4,000 of these products in the U.S. is due to a new packaging configuration that is confusing users as to how to orient the patch correctly.

Calhoun Vision raises $69M for light adjustable intraocular lens FDA approval, launch

Calhoun Vision has been around a long, long time for a startup. But now it's got a massive infusion of $69 million that's following on the heels of the addition of a new, market-focused CEO from Bausch + Lomb to help catapult it into commercialization.

St. Jude Medical gets FDA OK to resume trial of Portico TAVR

St. Jude Medical got FDA approval to resume a U.S. trial of its transcatheter aortic valve system, a win for the company as it recovers from safety concerns tied to the device last year.

Dexcom, Insulet partner with diabetes data startup Glooko as it expands into insulin pumps, CGMs

Glooko's mission is to integrate data from existing diabetes devices into an app for patients and a population management platform for payers and healthcare providers. It's diving into continuous glucose monitors and insulin pumps with a pair of deals--one for the Dexcom CGM and the other for the Insulet OmniPod pump.

Medtronic forks over $330M to resolve IRS spat

Medtronic is settling the score with the IRS regarding its previous acquisition of back surgery outfit Kyphon, shelling out $330 million during its fiscal fourth quarter to resolve the dispute with regulators.

Leadless pacemakers could become a gold mine for devicemakers, especially Medtronic

The leadless pacemaker market is one to keep an eye on over the next decade or so, says Bloomberg. Traditional ones are worth more than $3 billion per year.

Nevro cashes out JJDC, NEA and others with $150M and raises $90M for Senza launch

Shortly after its shareholder lock-up expired on May 5, Nevro has gone on to conduct a whopping $240 million stock sale. Of that, $150 million went to its selling shareholders, with Johnson & Johnson Development Corporation and Novo A/S leading the way.

Obalon completes enrollment in weight-loss balloon trial, as race for first U.S. approval heats up

Several companies are scrambling to sell the first non-surgically inserted intragastric balloon in the U.S. that reduces appetite by taking up space in the stomach.

Khosla-backed Thync dodges FDA, heads to market with $299 mood-shifting consumer wearable

Startup Thync has started to sell its forehead-adhesive consumer device intended to make users feel "more calm or energized" after FDA exempted the system from any regulation as a medical device. The startup said it is the first consumer wearable device that's marketed to improve a person's mood.

Congressional committee green-lights bill to repeal device tax

The push by the U.S. Congress to scrap the medical device tax put in place under President Obama's healthcare law two years ago got a boost, as a House committee signed off on a new bill to nix the tax.

FDA approves enhancement to only minimally invasive device for epilepsy

The FDA approved Cyberonics' pacemaker-like AspireSR generator to reduce seizures in patients with drug-resistant epilepsy. The generator is part of the company's VNS Therapy System.

Former Stryker R&D exec spins off new company with novel bone adhesive

New startup LaunchPad Medical has in-licensed a bone adhesive candidate from Stryker. The company is headed by a former R&D manager at Stryker, Brian Hess, who the company named Co-Innovator of the Year in 2010 for his work on this bone adhesive, Tetranite.

FDA clears first 'smart' spirometer, enabling continuous tracking of lung function via tablet

Cohero Health announced FDA clearance of the first spirometer for home use, enabling continued tracking of lung function between visits to the doctor via smartphone or tablet computer.

Aussie startup gets $11.5M to market FDA-cleared, wearable Parkinson's disease tracker

Melbourne, Australia-based Global Kinetics expects that its Personal KinetiGraph can offer a better way for physicians to monitor the progression of Parkinson's disease and other movement disorders in patients and to see how the disease symptoms respond to specific treatments. The device provides an objective, continuous quantification of movement disorder symptoms.

Pfizer, GE team up on cancer research

Pfizer will send GE biopsy samples for analysis using its MultiOmyx tumor analysis technology and services in a bid to get an upper hand in drug development.

Ishrak plays up four-point integration plan during Medtronic's earnings call

CEO Omar Ishrak touted Medtronic's four-point integration program during the company's first earnings report since its $50 billion acquisition of Covidien, saying he intends to achieve $850 million in cost synergies by the end of FY 2018.

Study: Migraine-prevention wearable helps brain metabolic activity return to normal

Belgium-based Cefaly Technologies already secured FDA approval for its headband-like device that stimulates the trigeminal nerve to reduce the frequency and intensity of migraines in March 2014. But now it has revealed positron emission tomography scan data showing that its Cefaly device can aid areas of the brain in returning to their normal metabolic rate in migraine patients.

Swedish med tech Elekta falls further on news of a reorg, continuing exec shuffle

Stockholm, Sweden-based Elekta will conduct a reorganization of the company and further alter its management line-up. This news follows upon the disclosure earlier this month of much weaker-than-expected earnings and the resulting departure of the company's CEO.