News

Health experts caution against wide range of scope devices amid superbug outbreaks

Duodenoscope devices have drawn the public's ire this past year, with the FDA and patients pushing back against the products in light of superbug outbreaks and mounting safety concerns. Now, healthcare officials are cautioning against a variety of scopes, saying similar devices could lead to potentially deadly infections.

Hospitals join feds in crackdown on physician-owned distributorships

Hospital operator OhioHealth is going to bar contracts with physician-owned distributorships by the fall.

Israeli med tech studies breath test in clinical trial for obesity-related cirrhosis candidate

The clinical evaluation of cirrhosis can rely upon a whole range of standard medical tests including hepatic venous pressure gradient (HVPG), liver biopsy results, and liver stiffness testing. But Israeli med tech Exalenz Bioscience is working to develop a breath test for its BreathID system that could offer accurate diagnosis and monitoring for a version of the disease, NASH cirrhosis in a Phase II clinical trial with biotech micro-cap Galectin Therapeutics.

U.S. Army scientists roll out innovative blood loss monitor device

As researchers target innovative technology geared toward military use, U.S. army scientists are developing a device that could monitor how long an individual is able to compensate for blood loss.

Medtronic, Bard get additional CMS reimbursement for their drug-coated angioplasty balloons

C.R. Bard announced that the federal Centers for Medicare & Medicaid Services has given the company new technology add-on payments for the Lutonix drug-coated angioplasty balloon to help hospitals cover the costs of treating patients with the device.

Emergent launches in-licensed military-grade autoinjector outside the U.S., aims for FDA approval

Emergent BioSolutions has launched a military-grade intramuscular autoinjector device for self-administered antidotes or other chemical threat treatments. For now, the rollout is only ex-U.S., but the infectious disease specialist said it will seek FDA approval for the device, dubbed Emergard.

Citing cybersecurity concerns, FDA says not to use Hospira infusion pump

In a strongly worded statement, the FDA told hospitals to stop using Hospira's Symbiq Infusion System because it can be remotely accessed by hackers, allowing the unauthorized user "to control the device and change the dosage the pump delivers, which could lead to over- or under-infusion of critical patient therapies." The agency's move marks another step to patrol the cybersecurity of medical devices, an issue that has long bedeviled Hospira's infusion pumps in particular. 

ResMed acquires China's Curative Medical to get bigger in sleep disorder devices

ResMed increased its focus on sleep disorder devices by acquiring China's Curative Medical for an undisclosed sum, in an attempt to gain a foothold in a fast-growing market.

Study of device tax reveals more about the impact of the ACA on Medicare reimbursement

The fight over the Affordable Care Act's 2.3% medical device excise tax has drawn various federal institutions into the fray, most recently the U.S. Government Accountability Office.

Wearable robotic leg rehabilitation device startup AlterG gets $15M in debt

Rehabilitation specialist AlterG has wrapped up $15 million in debt to back its products that include a leg-worn motor assistance device AlterG Bionic Leg as well as a low-gravity treadmill. The financing comes during an ongoing renaissance for novel mobility assistance devices.

Upstart gets $6M to back the first FDA-cleared OTC conception assistance device

Monroeville, PA-based startup Rinovum Women's Health has gained $6 million to back its commercialization efforts for its home-use conception assistance device that was cleared by FDA last fall. That's according to a SEC filing; the financing is an expansion of an infusion of just $700,000 it reported earlier this year .

Scientists create noninvasive spinal stimulation tech to help paralyzed move

Spinal cord stimulation is the med tech trend du jour, and researchers are harnessing the technology to create a noninvasive method that helps restore movement in paralyzed individuals.

Amid ongoing restructuring and layoffs at Siemens, healthcare leads

Healthcare was one of the strongest segments at German conglomerate Siemens last quarter, both in terms of sales growth and profitability. That could help insulate this business, comprised mostly of imaging and diagnostics, from an ongoing restructuring that aims to trim employees and costs from its worst performing businesses.

Lombard Medical gains a second stent graft for aneurysm repair via $50M acquisition

Endovascular aneurysm repair specialist Lombard Medical added a second endovascular stent graft to its portfolio with the acquisition of Silicon Valley's Altura Medical for up to $50.5 million.

CMS expands Medicare coverage of speech-generating devices

The Centers for Medicare & Medicaid Services announced that it is expanding Medicare coverage of speech-generating devices to include devices that generate written messages over email and text. Devices that enable Medicare recipients to electronically interface with a telephone to deliver speech via phone messages are also covered.

Abbott moves more into mitral valve med tech, to buy startup for $250M and options another

Abbott will buy two mitral valve replacement startups, moving it even further into med tech after a series of high-profile deals last year. It obviously sees the sector as a way for it to plan for long-term growth--since its innovative biopharma candidates went with AbbVie when the companies split in early 2013.

Congress proposes expanded access to mammograms in contradiction of expert recommendation

Reps. Renee Ellmers (R-NC) and Debbie Wasserman Schultz (D-FL) submitted a bill that would overrule a recent U.S. Preventive Services Task Force recommendation against insurance coverage for routine mammograms for women aged 40 to 49 for two years.

In a big week for obesity devices, GI Dynamics terminates U.S. pivotal obesity device trial

One of a handful of obesity devices aiming for the U.S. market has been sidelined. Australian company GI Dynamics has opted, after discussions with the FDA, to terminate its pivotal trial for its EndoBarrier due to safety concerns. The trial had already been placed on hold by the agency in March due to the incidence of hepatic abscess.

Zimmer Biomet wants sales reps to focus on cross-selling opps and non-large joints

Zimmer Biomet officials spent the newly combined company's Q2 2015 earnings call describing the company's sales and marketing strategy as it seeks to ramp up growth in 2016 following ongoing integration efforts. The company reiterated its pledge to retain sales reps rather than cut them in an effort to achieve synergies.

FDA clears device to protect caregivers from hazardous drug exposure

Iowa's Corvida Medical won the FDA's 510(k) clearance for its device to prevent healthcare workers from exposure to hazardous drugs, such as those used in chemotherapy.