Dive Brief Intuitive Surgical has paid $7.5 million for a nonexclusive license to most of Titan Medical’s intellectual property. The deal gives Intuitive access to patents related to the enhancement of robotic-assisted surgery, including ways to enter the body through a single access point. Titan licensed the patents after failing to find a company willing to buy its business. The failure of the search for a buyer led Titan to further reduce its headcount to lower its operating costs. Dive Insight Titan has been struggling for years. In 2019, cash constraints forced it to rethink its timeline for seeking 510(k) clearance for its single-port robotic surgical system. After further delays, the company started to look for strategic alternatives such as the sale of some or all of its business late last year. Titan contacted “over 55 potential counterparties,” it said in a statement. None of the parties expressed an interest ...
Dive Brief The U.S. Food and Drug Administration has approved Abbott’s spinal cord stimulation devices for the treatment of non-surgical back pain. Abbott landed the label expansion after showing its BurstDR spinal cord stimulation technology improved outcomes more than conventional medical management in people with chronic back pain who were ineligible for surgery. The label expansion comes 16 months after Nevro won FDA approval in non-surgical refractory back pain and four months after Boston Scientific released data on its rival device in the setting. Dive Insight: Abbott competes with Boston Scientific, Medtronic and Nevro for the spinal cord stimulation market and the four players are continually looking to expand into new areas where they are free from the intense competition that characterizes the core indications. Nevro unlocked an opportunity early last year, when it said it was the only company with specific labeling to treat non-surgical refractory back pain. Now, ...
Abbott (NYSE:ABT) today announced that it received FDA clearance for its Assert-IQ insertable cardiac monitor (ICM). The Assert-IQ device offers a new option for diagnostic evaluation and long-term monitoring for irregular heartbeats. It supplements Abbott’s portfolio of connected health devices for managing and treating patients remotely. The device could potentially rival the Medtronic Linq system. A small device with sensors inserted just under the skin of the chest, Assert-IQ provides constant, real-time monitoring. It can detect and identify arrhythmias that lead to symptoms like fainting, irregular pulse and shortness of breath. Abbott says many commercially available ICMs monitor hearts for “a few years,” but Assert-IQ offers two options. With a battery life of at least three or six years, it can provide doctors with a new level of flexibility in diagnostic monitoring. The three-year option offers a method for more traditional monitoring. That includes diagnosing fainting, heart palpitations or abnormal ...
Investigators also highlighted long-standing concerns that modified devices may bear little resemblance to the device originally FDA-approved. Katie Hobbins | Apr 19, 2023 Recently, a study published in JAMA Network Open reported that high-risk medical devices whose manufacturers file supplements to the FDA so modifications can be made to PMA-approved products are 30% more likely to be the subject of any recall and high-risk Class I recall. Makers of Class III PMA devices are offered five different types of supplements to allow for product improvements. Only one of the supplements — namely, panel track supplements — actually require clinical evidence for implementation and, as such, are the least-used type of the five, (approximately 1%). In contrast, the most used supplement type is a 30-day notice. A 30-day notice is used when a company makes changes to a manufacturing procedure or the way it makes a device. In the study, investigators analyzed devices approved through ...
Medtech’s resilience and flexibility have been clear to see during the COVID-19 pandemic. In this forward-looking view for 2022, CEOs from some of the Top 50 global medtechs share their perspectives on the present and the future, from company and health care system standpoints.
This will be the second recall on a heart device this month Medtronic’s Heartware device and accessories was recalled a few days ago. This comes after Abbott issued a patch to negate cybersecurity issues 350,000 remote monitoring systems and pacemakers.
This week, Bigfoot Biomedical announced a $55 million Series B to advance their push to integrate glucose monitoring, insulin delivery and smart software. The financing will support a pivotal trial and other efforts to gain premarket approval(PMA) from the FDA.
Medical device maker DexCom announced Tuesday that the company has received a de novo clearance from the FDA to sell its latest continuous glucose monitoring system — the G6 — that requires no fingerstick calibration.
mHealth tools embedded with AI technology are helping doctors and those living with diabetes detect hyperglycemia and hypoglycemia up to an hour ahead of time, averting serious and potentially fatal health issues.
Moody’s Investors Service has upgraded the financial outlook for the medical products and device industry from stable to positive, predicting that “continued product innovation” and synergies from acquisitions will drive growth of earnings before interest, depreciation and amortization (EBITDA) of between 4 and 5 percent over the next 12 to 18 months.
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