News

DEKA gets $7M from DARPA to develop prosthetic arm with a sense of touch

The Defense Advanced Research Projects Agency has re-upped in its long-standing relationship with DEKA Innovative Solutions. This time, it's putting $7 million into develop a prosthetic arm with a sense of touch.

Inspiration for novel medical devices could come from a seahorse tail

In a study reported in the journal Science, researchers examine the mechanical engineering involved in the shape of a seahorse's tail. They expect this research could have biomedical implications.

Researchers design fully implantable artificial pancreas with novel algorithm

Tightly and automatically matching the release of hormones such as insulin to control blood sugar levels for Type 1 diabetics is the Holy Grail in the development of an artificial pancreas. Now researchers may have come one step closer with a fully implantable insulin delivery and glucose sensing system that is guided by a novel algorithm.

Theranos grabs FDA approval for finger-stick herpes test

Silicon Valley startup Theranos snagged FDA approval for its finger-stick test for herpes, a feather in the company's cap as it looks to expand the reach for its product and challenge its rivals' business models.

Medtronic plays both sides: a new varicose vein adhesive found comparable to its ablation treatment

The latest data from Medtronic demonstrate just how wide its market reach extends. It found that a recently approved adhesive treatment for chronic venous insufficiency is comparable to radiofrequency ablation via a device that it also markets. That makes it seem like a win-win for the medical device giant, which now offers two equivalent, but distinct, treatment modalities.

Report: Despite growth in the device industry, effective concussion treatment remains elusive

Despite spending hundreds of millions of dollars on research and development, the jury is still out on whether medical devices and treatments designed to detect, prevent and treat head injuries are effective, The New York Times reported.

Allergan to buy dry eye device startup Oculeve for $125M+

Allergan will acquire clinical-stage dry eye device startup Oculeve for $125 million plus undisclosed commercial milestone payments tied to lead program, OD-O1. The somewhat stealthy startup came out of the Stanford Biodesign program and counts Kleiner Perkins Caufield & Byers, New Enterprise Associates and Versant Ventures among its investors.

FDA exempts 120 devices from 510(k) clearance requirements

The FDA said it will not enforce 510(k) clearance regulations on 120 low-risk classes of devices, making life easier for the device industry.

FDA approves a second placement confirmation test for Bayer's controversial Essure birth control device

It may be too little too late. But now the FDA has signed off on the use of transvaginal ultrasound as a means of ensuring the proper placement of the Essure permanent birth control device within three months of its insertion.

FDA warns that Maquet's anesthesia system could lead to a fatal stop in ventilation

On the heels of a permanent injunction from the Department of Justice that resulted in the cease of manufacturing at one of Maquet's facilities, the suspension of 5 of its devices from the market and a $6 million fine, the FDA just warned practitioners that the company's Flow-i Anesthesia Systems have a problem that "may cause anesthesia gas to leak and could prevent the ventilator from providing breathing support if not corrected immediately."

Proteus gains first FDA clearance specifically for measuring medication adherence

Proteus Digital Health first won an FDA nod for its ingestible sensor in 2012. But now it's gained an expansion of its label from the agency that indicates that the product can be used in the measurement of medication adherence. That makes it the first and only medical device to have gained this particular indication from the FDA.

GlySure gets CE mark for first continuous intravascular glucose monitor for hospital use

Managing blood glucose levels tightly helps improve morbidity and mortality rates among diabetics. That's particularly true for diabetics who have other major health problems. Now British startup GlySure has gained a CE mark specifically for use in intensive care units with adult cardiac surgery patients. Until now, blood glucose management for these critically ill patients often required frequent manual monitoring by the hospital staff.

Novartis launches navigation app for visually disabled on Apple Watch

Novartis launched its ViaOpta navigation app for the visually impaired on the Apple Watch, making it the first app of its kind to run on a smartwatch. It's also available on Android Wear.

Analysts: Roche sale of diabetes diagnostics unit could be a long time coming

After Bayer offloaded its diabetes device unit last month, some investors thought Roche would follow suit and sell its own underperforming diabetes diagnostics business. The Swiss drugmaker has experienced its fair share of problems with the unit, which stalled recently in light of price cuts and reimbursement issues in the U.S. But anyone expecting a sale of Roche's diabetes diagnostics business shouldn't hold their breath, analysts said.

Goldman Sachs says digital health to soon become $32B+ market

Goldman Sachs is bullish on telehealth, behavior modification, and remote patient monitoring technologies that are enabled by the rise of the "Internet of Things." The Wall Street firm believes digital health is soon set to earn as much as $32.4 billion in revenues, and could knock off $305 billion in healthcare costs in the short term.

PE firm Madison Dearborn to buy Patterson rehab business for $715M

Patterson Companies is up almost 2% on news that it plans to sell its medical business to private equity firm Madison Dearborn Partners for $715 million in cash. The company has been looking to sell this unit, which is focused on physical rehabilitation products, in order to focus more closely on its higher growth businesses in dental and animal health.

St. Jude launches study comparing its imaging tech to other modalities during stenting procedures

St. Jude Medical announced the launch of its third randomized clinical trial to compare the company's optical coherence tomography imaging to intravascular ultrasound and angiography alone. The three imaging systems will square off as a guide to stent implantation, which occurs during percutaneous coronary intervention procedures.

ViewRay gets $50M in debt to back MRI-guided radiation therapy after IPO withdrawal

ViewRay has nabbed up to $50 million in debt financing from healthcare investor CRG after canceling a proposed $52 million IPO in April. The cash will go to help commercialize its MRI-guided radiation therapy as well as to refinance existing debt.

Feds sentence woman to 97 months in prison for fraudulently billing Medicare for wheelchairs

The former owner of a medical supply company was sentenced to 97 months in prison for fraudulently billing more than $3.5 million to Medicare and Medi-Cal for unnecessary power wheelchairs.

Philips and Teva jump-start Israeli med tech incubator

Royal Philips and Teva Pharmaceutical Industries are getting the ball rolling on their new med tech incubator in Israel, sinking funds into two startups and planning more investments in the months ahead.