News

WSJ: Fetal ultrasound procedures are often not medically justified

As fetal-ultrasound procedures continue to increase in the U.S., medical experts are cautioning against running frequent scans with the devices.

NYT op-ed slams device breakthrough pathway proposed in 21st Century Cures Act

The 21st Century Cures Act promises to overhaul regulation of the medical device (and biopharma) industry if it passes the Senate. It just passed in the House of Representatives with a strong bipartisan majority. One of the main ways in which it would benefit the device industry is through the creation of a "breakthrough" pathway for critical medical devices.

Egg whites: A material of the future in med tech?

Researchers at the University of Georgia have discovered that bioplastics, especially components of egg whites, have many antibacterial properties when blended with additives like glycerol.

Startup begins major trial for duodenal resurfacing to treat Type 2 diabetes

Fractyl Laboratories has started a sizable clinical trial to test its noninvasive duodenal resurfacing technology as a treatment for insulin resistance in Type 2 diabetes patients. The news comes after the startup garnered a $40 million Series C round from investors including Mithril Capital Management last fall.

Indian stentmakers gaining global foothold--is U.S. market next?

Companies in India's diamond-cutting district in Surat, Gujurat, are applying their knowledge of lasers to create something else: stents.

FDA approves the first implantable, above-the-knee prosthesis

The U.S. Food and Drug Administration has approved an option for patients who have trouble with the standard socket leg prosthetics that are typically used for those with above-the-knee amputation. The implantable prosthetic requires two surgeries, but it's intended to encourage prosthetic usage and to improve patient outcomes.

EU funds development of a photonic-laser point-of-care cancer Dx device

European researchers from several companies and academic centers are working toward creating a photonic laser-based device that would enable the diagnosis and monitoring of cancer patients in the physician's office. The four-year project is funded via Horizon 2020, the largest and latest EU R&D initiative that's investing a total of almost €80 billion ($86.9 billion) from 2014 to 2020 to stimulate technology transfer.

3-D cell imaging outfit VisionGate eyes $75M IPO

Arizona's VisionGate is gearing up for an IPO, making plans to go public to spur development of its 3-D cell microscope technology for early lung cancer detection.

Study finds Philips ventilator helps reduce hospital readmissions for COPD

Philips touted a study in the Journal of Clinical Sleep Medicine concluding that the company's portable home ventilator greatly reduced hospital readmissions among COPD patients.

FCC clarifies regulations on medical devices that use radiofrequency

The Federal Communications Commission said that investigational devices that employ radiofrequency can receive reimbursement to cover the costs of a clinical trial, like other devices.

BD opens new diabetes R&D center to develop, manufacture next-gen products

Becton Dickinson has opened the doors of a new facility in Andover, MA, that's dedicated to R&D and manufacturing for novel products to better address the needs of Type 1 and Type 2 diabetes patients. The center is part of a renewed effort for BD in diabetes, after it has suffered difficulties due to pricing erosion.

Malaysian government approves 11 med tech projects worth $120M+

The federal Malaysian Investment Development Authority has approved 11 med tech projects worth 464.6 million Malaysian ringgit ($122.02 million) estimated to create 1,633 jobs, as the country aims to become a medical device hub.

FDA gives its first nod to St. Jude for an Apple-compatible device to try out pain neurostim implant

The U.S. Food and Drug Administration may have made it a bit easier for chronic pain patients to evaluate whether a spinal cord stimulator could be an effective treatment. For the first time, it's approved a wireless, external device from St. Jude Medical that can be manipulated via an Apple iPod touch, rather than a dedicated controller that's likely to be less intuitive to patients.

Alere keeps diagnostics ball rolling with new deals and quick strep test win

Alere recently sold off its BBI Diagnostics unit, scooped up a new diagnostics company and nabbed an FDA CLIA waiver for its quick strep test, helping the company distance itself from its troubled past.

Survey: Docs expect HeartWare's blood pump to get expanded indication from FDA despite worrisome trial data

Citing a just-released survey of cardiologists and thoracic surgeons, Leerink equity analysts said that a clinical trial finding a stroke rate of 31% among heart failure patients on the HeartWare Ventricular Assist Device will not affect clinical affect decision making.

Novartis, PPD conduct clinical pilot study using medical device connectivity via a smartphone app

Startup Clinical Ink said that it's in the midst of a pilot clinical study that incorporates medical device data that's collected through a smartphone app with biopharma Novartis and contract research organization PPD. The trial incorporates medical device connectivity that's provided by Clinical Ink and powered by Qualcomm's 2net Mobile Platform.

Woven Orthopedic raises $6.6M for device to keep implant screws tight

Connecticut's Woven Orthopedic Technologies has raised $6.6 million in equity financing, bringing its total haul to near $10 million since 2013.

NSF spends almost $31M to develop dissolvable metal surgical implants

The National Science Foundation has coughed up almost $31 million since 2008 in an effort to develop what it has dubbed "smart implants" that address the underlying medical issue but then dissolve.

China FDA: Unannounced inspections are around the corner

China's version of the FDA, or CFDA, announced that it will begin conducting unannounced inspections of medical device companies' manufacturing and development efforts starting Sept. 1, as it looks to step up its oversight of the industry.

Courtagen reels in $20M for genetic pediatric neurology disorder tests

Massachusetts startup Courtagen roped in $20 million to support development of its genetic tests for pediatric neurology disorders, a boon for the company as it rolls out new products and diversifies its diagnostics portfolio.