From Accuray’s India approval to Masimo and PositiveID launching a Bluetooth-enabled thermometer, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. India approves Accuray’s Radixact X9 radiation therapy device Accuray announced in a June 21 press release that it has received an Atomic Energy Regulatory Board Type Approval in India
Johnson & Johnson launches new self-shortening Dynacord suture
June 20, 2018 By Leave a Comment
Johnson & Johnson through its DePuy Synthes franchise has announced the U.S. launch of its Dynacord suture for soft tissue repair in areas such as the rotator cuff in the shoulder. The Dynacord suture, available on Healix Advance anchors, is part of the DePuy Synthes Mitek Sports Medicine portfolio. J&J launched Dynacord today at the San
SetPoint Medical touts 2-year relief from rheumatoid arthritis
June 19, 2018 By Leave a Comment
Startup SetPoint Medical has demonstrated “significant, sustained improvement” over two years in a first-in-human study using bioelectronic therapy in patients with rheumatoid arthritis (RA). Seventeen subjects with moderate to severe symptoms were implanted with a vagus nerve stimulator in the European study. At three months, the therapy was shown to have significantly reduced RA symptoms
Paragonix Technologies aims to boost survival of donated lungs
June 18, 2018 By Leave a Comment
Many lungs being transported for transplant arrive in such bad shape that they cannot be used. Paragonix Technologies aims to change that with SherpaLung, a specialized cooler that keeps lungs properly inflated and at the right temperature to survive an airplane trip. Paragonix Technologies just landed support from the Lung Transplant Foundation to continue developing and commercializing
Here’s how FDA officials think you can legally promote off-label device, drug uses
June 13, 2018 By 2 Comments
The FDA has issued final guidance clarifying what it considers permissible off-label information for device makers and drug companies to convey to potential customers. A pair of guidance documents outlines how medtech and pharmaceutical companies can explain to payors and hospitals how their products can affect outcomes and potentially save money, beyond what the products’ indication with the
Medtech companies need to expand their philosophy: Here’s why
June 12, 2018 By Leave a Comment
Medtech companies should expand their notion of who their customers are and dig deeper to discern what those customers want, according to health provider- and insurer-connected experts at the recent DeviceTalks Minnesota in St. Paul. Artificial intelligence and the proliferation of healthcare data have made it possible for medtech to consider not just individual patients
Sanford Health and Freudenberg Medical partner on infusion systems
June 11, 2018 By Leave a Comment
Sanford Health (Sioux Falls, S.D.) and Freudenberg Medical (Carpinteria, Calif.) announced that they have entered a joint research and development agreement to develop infusion systems to treat blood clots and blockages in blood vessels. A catheter used in the infusion systems was designed by vascular surgeon Dr. Patrick Kelly at Sanford Health Innovations, a part of
Medtech stories we missed this week: June 8, 2018
June 8, 2018 By Leave a Comment
From Royal Philips receiving FDA clearance to NeuroPace launching its epilepsy treatment device, here are seven medtech stories we missed this week but thought were still worth mentioning. 1. FDA clears Philips’s Ingenia Elition 3.0T MR scanner Royal Philips announced in a June 5 press release that it has received FDA 510(k) clearance for its Ingenia
Olympus launches electrosurgical knife to shorten procedure times
June 5, 2018 By Leave a Comment
Olympus recently announced that it has launched its DualKnife J endoscopic submucosal dissection (ESD) electrosurgical knife that uses submucosal injection to support safe and reliable ESD performance. “DualKnife J allows us to further innovative ESD procedures as part of an overall value-based care initiative, providing more minimally invasive procedures to patients so they may reap
Medtech veteran Mir Imran wants to replace injections with the ‘robotic pill’
June 4, 2018 By Leave a Comment
Companies have tried for decades to deliver protein-based drugs orally. Can Mir Imran and his company’s robotic pill succeed where so many have failed? Mir Imran has been building medical device companies for 40 years. Perhaps known best for his work on the first FDA-approved implantable cardioverter defibrillator, Imran’s model is to identify big, unsolved
Power morcellation: Questions linger for controversial tech
June 1, 2018 By 4 Comments
Dr. Amy Reed’s tragic case brought to light the cancer risks posed by power morcellation. Her death hasn’t stopped lingering questions about the technology. Power morcellators were used for 20 years to laparoscopically remove fibroids, benign tumors of the uterus, raising not a single adverse event report with the FDA. That all changed in 2013,
This robotic system can automatically adjust ultrasound equipment
May 30, 2018 By Leave a Comment
Neural Analytics today announced that it has won FDA clearance for a robotic system that can automatically adjust the company’s ultrasound equipment to monitor blood flow through the brain from outside the body. NeuralBot was designed to work with the company’s previously approved Lucid M1 transcranial Doppler ultrasound system, a portable all-in-one ultrasound system designed
Brain emergency averted at the push of a button
May 29, 2018 By 3 Comments
A Boston neurosurgeon recently avoided doing emergency brain surgery on a young patient just by pressing on a new device. The Alivio ReFlow ventricular system was embedded beneath the scalp of the unidentified hydrocephalus patient. Comprised of a subcutaneous “flusher” component and a ventricular catheter, the device has a “relief membrane” backup feature at the catheter’s
How ingestible bacteria-on-a-chip could diagnose gastrointestinal diseases
May 25, 2018 By Leave a Comment
Massachusetts Institute of Technology researchers have developed an ingestible sensor that has engineered bacteria that can diagnose bleeding in the stomach and has the potential to diagnose other gastrointestinal problems. The system, being called bacteria-on-a-chip, uses sensors with living cells and ultra-low power electronics that can convert a bacterial response into wireless signals that can
These building blocks are making plug-and-play diagnostic devices
May 24, 2018 By Leave a Comment
Massachusetts Institute of Technology researchers have created a set of modular blocks that can be connected in different configurations to create diagnostic devices. The devices are considered plug-and-play and can test blood glucose levels, detect viral infection and other diseases. “Our long-term motivation is to enable small, low-resources laboratories to generate their own libraries of
