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Medtronic Diabetes unit fully resolves FDA warning letter

Medtronic (NYSE:MDT) announced today that the FDA lifted the warning letter related to its Diabetes business unit headquarters.

In December 2021, the FDA issued a warning letter to Medtronic’s Northridge, California, Diabetes headquarters.

The letter centered around the inadequacy of specific medical device quality system requirements at the Northridge facility. It scrutinized the areas of risk assessment, corrective and preventive action and complaint handling. The letter also related to device recalls and the reporting of adverse events.

Medtronic said today that the resolution follows ongoing remediation from the company. It took proactive actions to continue to strengthen its quality systems, according to a news release. All regulatory restrictions associated with the letter are resolved, the company said.

Get the full story at our sister site, Drug Delivery Business News.

Fast Five: Philips announces recall litigation provisions, Boston Scientific could be eyeing a billion-dollar acquisition

Welcome to the MassDevice Fast Five medtech news podcast, the show that keeps you up-to-date on the latest breakthroughs in medical technology. Here’s what you need to know for today, April 25, 2023.

Fast Five by MassDevice · Philips’ new recall litigation provisions, Boston Scientific could eye billion-dollar acquisition

More diabetes and robotic surgery innovations are in the news today. The FDA approved Medtronic’s newest iteration of its MiniMed insulin pump. Sean Whooley gives a detailed look at the newest device and what sets it apart from other versions.

Philips has been dealing with a series of recalls related to its Respironics line of devices. This week, the company posted Q1 earnings and announced recall litigation provisions. Hosts Danielle Kirsh and Whooley discuss what that means for the company and what investors have to say about it.

Smith+Nephew is a major player in the robotic-assisted surgery market with its…

FDA clears stroke treatment system from Route 92 Medical

The FreeClimb 70 Reperfusion System. [Image courtesy of Route 92 Medical]Route 92 Medical announced that it received FDA 510(k) clearance for its FreeClimb 70 reperfusion system for treating ischemic stroke.

San Mateo, California-based Route 92 designed the reperfusion system with the FreeClimb 70 aspiration catheter. It also features a Tenzing 7 delivery catheter.

The system enables physicians to treat patients experiencing acute ischemic stroke by removing clots rapidly and safely. Route 92 said it offers a more refined bi-axial approach for restoring blood flow to the brain during endovascular thrombectomy procedures.

Dr. James Caldwell, an early user, said the system offers easily delivery to the target occlusion for effective, safe reperfusion. Caldwell used the system at Auckland City Hospital in Auckland, New Zealand.

“Tenzing-based delivery can reduce procedure time and may reduce complications,” Caldwell said.…

Abbott wins duo of FDA clearances for CentriMag life support system

The CentriMag life support system. [Image from Abbott]Abbott (NYSE: ABT) + announced today that it received two FDA clearances for its CentriMag system for life support.

The agency cleared the CentriMag blood pump for longer-term use in adults using the CentriMag system. These adults require extracorporeal membrane oxygenation (ECMO) to save their life. Longer-term support provides physicians more time to assess the next steps and make critical care decisions for patients.

Additionally, Abbott won FDA clearance for the new CentriMag pre-connected pack. This packaged system offers several pre-connected components of the CentriMag system. The company said in a news release that it accelerates the deployment of the life support system.

Combined, the clearances build out Abbott’s ability to offer leading life support systems, the company said.

About the new Abbott CentriMag clearances Adult pump of the Centri…

3M is laying off thousands of additional workers

3M (NYSE: MMM) + announced today that it will reduce its headcount by 6,000 — on top of the previously announced 2,500.

It was unclear how many of the jobs are in the company’s Health Care business, which 3M remains on track to spin off. The total 8,500 jobs getting cut represent nearly a tenth of the manufacturing giant’s global workforce.

3M officials expect the restructuring initiative to save the company $700–900 million a year before taxes. They plan to save money by reducing the size of the company’s corporate center, simplifying the supply chain, streamlining the company’s geographic footprint and reducing management layers. 3M will also streamline its go-to-market models to more closely align with customers’ needs.

“We’re confident that these are the right actions about positioning us for growth and profitability as we go forward. And it’ll help us navigat…

Orthofix launches two access retractor systems for spine procedures

[Image courtesy of Orthofix]Orthofix Medical (Nasdaq:OFIX) + today announced it launched two access retractor system to help surgeons during minimally invasive spine procedures.

The company commercially launched the Lattus lateral access system and the Fathom pedicle-based retractor system to expand its offering of access solutions.

Orthofix designed Lattus for ease of use and versatility. The blade retraction strength and “down-and-out” splay feature give access to challenging anatomy. Used in combination with a full suite of instrumentation that uses the company’s innovative WaveForm L and Regatta NanoMetalene interbody devices, the Lattus retractor system can optimize the lateral procedure, according to the company.

“The Lattus Lateral Access System addresses five important areas of lateral spine surgery: access to the spine, preparation or removal of the disc, interbody placement, plate fixati…

GE HealthCare stock is down despite Street-beating Q1

GE HealthCare shares took a hit today despite first-quarter results that topped the consensus forecast.

Shares of GEHC were down more than 9% to $79.83 apiece by afternoon trading today. Some suggest disappointment that the company didn’t raise its guidance as the reason behind that dip. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — fell more than 1%.

GE HealthCare reaffirmed its guidance for 2023 with its sales growth range of 5% to 7% mentioned by Arduini. The company projects adjusted EPS to range between $3.60 to $3.75. BTIG analyst Ryan Zimmerman noted that investors expected a guidance raise. That may impact the reaction on the market.

Additionally, Zimmerman pointed out that investors may look negatively upon a decrease in orders. Combined with the guidance and a “normalized growth cadence,” GE HealthCare could face a “tougher set-up” through the y…

FDA clears basal-only insulin pod for type 2 diabetes from Insulet

The Omnipod GO insulin delivery system. [Image courtesy of Insulet]Insulet (Nasdaq:PODD) announced today that it received FDA clearance for its Omnipod GO long-acting insulin delivery device.

Omnipod GO, which received clearance for people with type 2 diabetes aged 18 or older, covers the basal-only insulin population. The target population typically takes daily injections of long-acting insulin.

The first-of-its-kind, standalone, wearable insulin delivery system provides a fixed rate of continuous, rapid-acting insulin for 72 hours. It features a tubeless and waterproof pod offered in seven different pre-programmed daily rates. These rates range from 10 to 40 units per day.

Insulet developed the product to serve the type 2 diabetes population earlier in their treatment journey. This technology starts them on pod therapy — built on Insulet’s longstanding Omnipod platform — for insulin delivery, rather than daily injections. If a patient becomes insulin-inte…

FDA clears surgical navigation system from Proprio

The Paradigm surgical visualization system. [Image courtesy of Proprio]Proprio announced today that it received FDA 510(k) clearance for its Paradigm surgical navigation platform.

Seattle-based Proprio designed Paradigm to replace traditional surgical navigation technologies. Using an advanced approach, it avoids the pitfalls that pull attention away from the patient and disrupt workflows.

According to a news release, Paradigm is the first such system to use light field technology in spine surgery navigation. This process creates a real-time view of the anatomy and surgical scene, Proprio said. The system features an advanced sensor suite to capture high-definition, multi-modal intraoperative images. It then fuses that information with preoperative scans.

With the platform, surgeons can access helpful data, Proprio said. That includes intraoperative imaging and powerful visualization capabilities. Plus, it operates without any harmful ra…

The future of rapid and enduring neuropsychiatric treatments: From psychedelics to non-hallucinatory psychoplastogens

Serotonin molecule [Vladimir/Adobe Stock]

Neuropsychiatric disorders, such as depression and anxiety, are among the leading causes of disability worldwide. Almost one billion people globally — roughly one out of eight individuals — live with a mental disorder, with anxiety and depressive disorders the most common, according to the World Health Organization. Yet current therapies such as selective serotonin reuptake inhibitors (SSRIs) offer limited efficacy and come with undesirable side effects. Additionally, they may take weeks to produce noticeable benefits.

These challenges have sparked interest in alternative treatments, including psychedelics and psychoplastogens, for mental health treatment, as noted by Dr. Kurt Rasmussen, Delix‘s chief scientific officer. “There are now a lot of researchers looking at psychoplastogens as a way to help remodel those circuits and treat depression and anxiety mor…

Pharma M&A resurgence: An overview of recent deal-making trends

[Yingyaipumi/Adobe Stock]

After something of a slow year in 2022, mergers and acquisition (M&A) activity is ramping back up in the pharma and biotech sector. There have been several especially large M&A deals in the past few months. Examples include Pfizer’s (NYSE:PFE) $43 billion acquisition of Seagen, and Merck’s (NYSE:MRK) $11 billion purchase of Prometheus Biosciences. In December 2022, Amgen (Nasdaq:AMGN) said it would scoop up Horizon Therapeutics for almost $28 billion.

What’s fueling the M&A uptick?

Factors driving the uptick include an upcoming patent cliff from 2026 to 2029, pricing pressure from the U.S. Inflation Reduction Act and lower equity valuations, according to Moody’s Health Care Quarterly: April 2023.

For instance, the Amgen acquisition of Horizon could help the firm offset a potential $30 billion sales shortfall it may face as a result of growing b…

Unraveling the impact of FDORA and PREVENT Pandemics Acts on the life sciences

[freshidea/Adobe Stock]

As the world continues to grapple with global health challenges, the role of science and biotech law has taken center stage in shaping public health policy and innovation. The FDORA and PREVENT Pandemics Acts are poised to help shape the landscape.

In a recent interview, life sciences attorney Barbara Binzak Blumenfeld offers insights into significant recent legislative, judicial, and regulatory developments, including the planned end to the COVID-19 Public Health Emergency (PHE), the enactment of the Food and Drug Omnibus Reform Act (FDORA), and the Prepare for and Respond to Existing Viruses, Emerging New Threats, and Pandemics Act (PREVENT Pandemics Act).

With a Ph.D. in molecular biology, Blumenfeld is well-versed in the scientific, ethical, and legal issues that are pivotal in the life sciences. In a recent interview, she touched on the expiration of the COVID-19 Public Health…