The FDA cleared the first robotic exoskeleton as an everyday mobility aid a little over a year ago for ReWalk Robotics--which subsequently and spectacularly went public last November in an IPO. But ReWalk is scarcely alone, even on the public markets.
Spectranetics' AngioScore unit scored a victory in its breach of trust suit against a former board member, as a U.S. District Court ruled in the company's favor and ordered the defendants to fork over $20 million.
Procept BioRobotics has rounded up $42 million to get through a pivotal trial of its water-based ablation technology to potentially treat benign prostatic hyperplasia without the side effects seen with heat-based ablation, which include bleeding, dysuria, incontinence and sexual dysfunction.
Efforts to repeal the tax on medical devices that has helped fund the Affordable Care Act are gaining more traction in Congress following the U.S. Supreme Court's landmark decision supporting a key point of the law, The Wall Street Journal reports.
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.
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.
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.
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.
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.
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 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.
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.
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 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.
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 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.
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 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.
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.