FDA has cleared RFPi’s iCertainty real-time, noninvasive blood flow and perfusion imaging medical device for use during surgical procedures, the company said. iCertainty is the first medical imaging device to show blood flow without interrupting a surgical procedure or requiring injections, dyes, radiation or direct patient contact, according to the Greenville, N.C. company. Use of iCertainty during surgery could reduce […]
Kyocera buys part of Renovis Surgical
Kyoto, Japan-based Kyocera (TYO:6971) said it will buy the major assets of Renovis Surgical Technologies’ artificial joint and spinal products businesses to expand its U.S. footprint. Kyocera will transfer the assets into a new, wholly owned, California-based company to be named Kyocera Medical Technologies in March 2019. Kyocera manufactures medical products, including artificial joints and dental implants, primarily for […]
Researchers develop speedy 3D printing
University of Michigan researchers said they have developed a 3D printing method that’s up to 100 times faster than conventional 3D printing processes. Rather than building up plastic filaments layer by layer, the new approach lifts complex shapes from a vat of liquid at high speed, potentially allowing manufacturers to produce up to 10,000 […]
How AI can detect cervical cancer
Researchers have developed a computer algorithm that they say can analyze digital images of a woman’s cervix and accurately identify precancerous changes that require medical attention. This artificial intelligence approach, called automated visual evaluation, has the potential to revolutionize cervical cancer screening, particularly in low-resource settings. Led by investigators from the National Institutes of Health […]
FDA adds back some workers during partial government shutdown
The FDA has resumed several health and safety activities that had been halted by the partial government shutdown, now in its 24th day. In a series of tweets on Sunday, FDA Commissioner Scott Gottlieb, M.D. listed the tasks that the agency has added to “excepted, unpaid work.” “It is not business as usual at FDA. Many key functions […]
Cook Medical to market Zelegent’s ‘facelift for the soft palate’
Just a month after receiving FDA 510(k) approval for its new anti-snoring device, startup Zelegent has signed a marketing agreement with Cook Medical, the companies announced. Zelegent’s Elevo kit snoring intervention device employs specially shaped, resorbable, barbed sutures to lift the soft palate by1-4 millimeters, expanding the mean diameter of the airway. In a typical snoring patient who doesn’t have […]
Genae buys regulatory affairs company MedicSense
Medical device contract research provider Genae (Antwerp, Belgium) recently acquired MedicSense, a clinical, regulatory affairs and quality assurance consultancy firm based in Tel Aviv, Israel. Terms were not disclosed. “The vast regulatory and quality assurance expertise of the MedicSense team represents a logical expansion of Genae’s value chain of services,” said Genae CEO Bart Segers in a prepared statement. […]
Empatica’s pediatric seizure-predicting smartband wins FDA nod
Empatica said that its Embrace epilepsy smartband has received 510(k) clearance from FDA for use in children, a year after winning clearance for adults with epilepsy. Embrace was designed to detect motion patterns and physiological signals that may be associated with generalized tonic-clonic (“grand mal”) seizures and immediately alert caregivers. It is the first non-EEG based, […]
The Danes are coming to Medical Alley
A delegation of Denmark’s medtech and health leaders is traveling to Minnesota’s Medical Alley next week to solidify a partnership with Denmark’s MedTech Bridge. MedTech Bridge is a nonprofit program established to expand the relationship between medical device and digital health companies in Denmark and the United States and to scale commercial-stage Danish medtech businesses in the U.S. […]
Cynerio poised to enter U.S. healthcare cybersecurity market
Cynerio said it has completed a $7 million funding round to fuel growth in North America for its healthcare-focused cybersecurity platform. Investors include global venture capital firms, Accelmed, an unidentified medtech investment firm, and RDC, and RDC, a joint venture between Israeli investment firm Elron and Israeli defense systems manufacturer Rafael. Get the full story on […]
10 of the best performing medical device stocks of 2018
Updated Jan. 8, 2019 Medical device company stocks are not looking as rosy as they did two months ago, but the medtech industry still appears to be resisting the overall downward trend in stock markets, according to a Medical Design & Outsourcinganalysis. More than half of the roughly 100 largest medical device companies in the world […]