Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices.
Lake Oswego, Oregon-based Biotronik designed its Renamic Neo programmer for implanted devices, including ICDs, pacemakers and implantable cardiac monitors.
Get the full story at our sister site, MassDevice.
The FDA today announced a Class I recall — the most serious kind — for the Medtronic (NYSE:MDT) Harmony delivery catheter system.
Medtronic designed the Harmony transcatheter pulmonary valve (TPV) system for treating a leaky native or surgically repaired right ventricular outflow tract (RVOT). It consists of a transcatheter pulmonary valve and a delivery catheter (the Harmony delivery catheter) that allows for the implantation of a replacement valve without open-heart surgery.
The FDA approved the device, described by Medtronic as a first-in-the-world, non-surgical heart valve to treat severe pulmonary valve regurgitation, in March 2021.
Get the full story at our sister site, Medical Tubing + Extrusion.
FDA has announced that it has signed off on the use of COVID-19 therapy Veklury (remdesivir) from Gilead Sciences (Nasdaq:GILD) to include children at least 28 days old who weigh at least 3 kg (roughly 7 lb) and test positive results for COVID-19.
The indication is limited to children who are either hospitalized or have a high risk of developing severe COVID-19, including hospitalization or death.
In October 2020, remdesivir became the first FDA-approved COVID-19 treatment and is now the first drug to win approval for children under 12 years of age.
Remdesivir was formerly authorized for use in young children under emergency use authorization but was FDA-approved for COVID-19-infected individuals at least 12 years old who weigh at least 40 kg (roughly 88 lb).
“As COVID-19 can cause severe illness in children, some of whom do not currently have a vaccination option, there continues to be a need for safe and effective COVID-19 treatment options for …
Biotronik announced today that the FDA approved its Renamic Neo programmer for implanted cardiac rhythm management devices.
Lake Oswego, Oregon-based Biotronik designed its state-of-the-art Renamic Neo programmer for implanted devices including ICDs, pacemakers and implantable cardiac monitors.
According to a news release, Renamic Neo offers LifeSupport for clinicians to share the programmer screen with or grant programmer control to Biotronik technical support personnel at remote locations. It has compatibility with Biotronik’s ReportShare and EHR DataSync to allow for the secure and easy integration of programmer data into hospitals’ EHR systems.
Renamic Neo also has a 12-inch, high-resolution, high-contrast LCD touch screen display, a built-in analyzer and battery-powered portability. The company said the system is also significantly lighter and smaller than the previous iteration. Biotronik will make the platform available in the U.S. soo…
Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.
“At this time, it’s a subpoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation, and we just have to accept that.”
Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.
Van Houten said Phillips remains in close collaboration and contact with regulatory agencies.
…Royal Philips CEO Frans van Houten [Photo courtesy of Philips]
Royal Philips (NYSE:PHG) today disclosed a Department of Justice subpeona for information related to the massive recall of Respironics respiratory devices.Philips Respironics and Philips subsidiaries in the U.S. received the subpoena on April 8 seeking “information related to events leading to the Respironics recall,” the Amsterdam-based company said as it announced its latest financial and operating results. Phillips said its subsidiaries are cooperating with investigators.
“At this time it’s a subpeoena for information,” CEO Frans van Houten said on today’s earnings call. “That means they are preparing an investigation and we just have to accept that.”
Philips shares dropped about 12% in trading Monday as the company detailed continued supply chain struggles and mounting recall costs.<…
After winning FDA approval for the controversial Alzheimer’s drug Aduhelm (aducanumab) in June 2021, Biogen (Nasdaq:BIIB) has encountered a string of setbacks.
Most recently, the company has decided to yank its applications for market approval after the European Medicines Agency (EMA) recommended the refusal of the marketing authorization for Aduhelm in December 2021.
At that time, Biogen announced that it would fight the decision.
In April, the company notified EMA that its decision to withdraw its application was “based on interactions with the CHMP [Committee for Medicinal Products for Human Use] indicating that the data provided thus far would not be sufficient to support a positive opinion on the marketing authorization of Aduhelm (aducanumab).”
“We are thankful to the patients, caregivers and physicians that supported the re-examination process as part of the EMA review,” said Dr. Priya Singhal, head of global safety and regulatory sciences …
Quanterix (Nasdaq:QTRX) announced today that it received FDA breakthrough device designation for a multiple sclerosis (MS) diagnostic.
Billerica, Massachusetts-based Quanterix designed its Simoa neurofilament light chain (NfL) plasma test as a prognostic aid in assessing the risk of disease activity in patients diagnosed with relapsing-remitting MS (RRMS).
According to a news release, the company designed the digital immunoassay to quantitatively measure NfL in human serum and plasma. It has shown promise in conjunction with clinical, imaging and laboratory findings as an aid in identifying RRMS patients who are at lower or higher risk for relapse within four years, offering assistance in tailoring the therapeutic approach to more effectively treat the disease.
The breakthrough nod follows the publishing of a large-scale, international study in The Lancet Neurology. The study demonstrated that the ultra-sensitive Simoa technology helped establish a new m…
[Image via Blogtrepreneur on Flickr, per Creative Commons 2.0 license]
Medical device companies face heightened cybersecurity burdens, antitrust enforcement and supplier risks, according to a new report out of Moody’s.The research firm’s previous quarterly report in February called attention to continued supply chain and labor problems for medtech.
Below are the key highlights for medical device companies from the latest report.
Medical device cybersecurityThe report flagged legislative proposals for new rules and regulations on medical device developers and manufacturers, including new cybsecurity rules.
“The industry is ripe for increased oversight of cyber risks,” the analysts wrote in their report. “We have identified the sector as having a medium high exposure to cyber risk. And our survey of rated healthcare issuers indicates that medical de…
The company designed the portable automated peritoneal dialysis (APD) system (from Fresenius Medical Care North America) as a light, simple, quiet, portable and advanced platform for improving health equity by making home therapy a more feasible option for a broader population of dialysis patients.
According to a news release, FDA clearance makes the Versi PD cycler system the lightest, smallest and quietest dialysis cycler in the U.S.
The company developed VersiPD to allow patients to enjoy restful sleep through its near-silent operation, with fewer disruptive alarms and a night mode option. The cycler also has the capability of more personalized prescription programming to meet the individual needs of a wide range of patients.
VersiPD includes a touchscreen and embedded videos with audio guidance to assist pa…
It doesn’t get any bigger than Amazon in the world of cloud computing.
Dr. Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.Dr. Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.
“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.
Get the full story at our sister site, Medical Design & Outsourcing.
Taha Kass-Hout is the chief medical officer and director of machine learning at Amazon Web Services [Photo courtesy of Amazon]
It doesn’t get any bigger than Amazon in the world of cloud computing.The Amazon Web Services cloud computing business at Seattle-based Amazon.com (Nasdaq: AMZN) is the largest player in the industry, with control of about a third of the market and a significant lead over cloud competitors Microsoft and Google.
Taha Kass-Hout, the chief medical officer and director of machine learning at AWS, spoke with Medical Design & Outsourcing as part of an ongoing series of conversations about cloud computing’s contributions to medtech and the potential ahead.
“The future is bright for anyone who’s trying to solve problems in healthcare and life science globally,” he said.
This conversation has been edited for clarity and length.
MDO: What d…