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How medical device companies can better protect themselves from lawsuits

Getting hit with lawsuits isn’t an if, but a when for medical device developers and manufacturers. A veteran Greenberg Traurig lawyer shares advice for staying secure.

[Image from Pixabay]

As with pharmaceutical companies and health providers, medtech is emerging from the COVID-19 pandemic with a great deal of goodwill, says Ginger Pigott, a Greenberg Traurig shareholder. Pigott has seen the industry’s improved image helping device companies with juries, mock juries and the litigation process in general.

But don’t bet on the trend lasting.

“I’ve been practicing for 30 years, and it goes in that cycle all the time,” Pigott said in a recent interview with Medical Design & Outsourcing. (Pigott will moderate a panel about building startups to last at DeviceTalks West, Oct. 19-20, 2022 in Santa Clara, California.)

In fact, Pigott suspects the present economic unc…

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HeartBeam enables smartwatch connectivity for heart monitoring

HeartBeam (Nasdaq:BEAT) announced today that it expanded its product portfolio to add arrhythmia detection capabilities to wearables.

Santa Clara, California-based HeartBeam said in a news release that it aims to serve the growing cardiac device wearable market. The pipeline advancement allows for the addition of arrhythmia detection capabilities for AFib and other arrhythmia monitoring.

The company’s broader product portfolio builds on recently issued patents, HeartBeam said. Its 12-lead electrocardiogram (ECG) patch picked up a patent last month.

HeartBeam introduced a three-lead 3D vector ECG (VECG) credit card-sized HeartBeam AIMIGo 3L device. The device records cardiac activity and displays signals for clinician review. It provides the regulatory foundation for subsequent products in the company’s portfolio. HeartBeam plans to submit to the FDA for 510(k) clearance in the fourth quarter of this year.

Additionally, the company leve…

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AngioDynamics slides on Q1 misses

AngioDynamics (Nasdaq:ANGO) shares took a hit today on first-quarter results that came up shy of the consensus forecast.

Shares of ANGO dipped 12.6% at $18.84 apiece as the market opened today. MassDevice’s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — was up 0.5%.

The Latham, N.Y.-based peripheral artery disease (PAD) treatment developer posted losses of $13 million, or 33¢ per share. It registered sales of $81.5 million for the three months ended Aug. 31, 2022, for an 86.5% bottom-line slide deeper into the red on sales growth of 5.9%.

Adjusted to exclude one-time items, losses per share were 6¢, 4¢ behind Wall Street, where analysts were looking for sales of $83.4 million.

The company reported net medtech sales of $22.8 million. Growth drivers there included the Auryon peripheral atherectomy platform, the thrombus management platform and the NanoKnife irreversible electroporation platfor…

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Study shows reduced HbA1c with Abbott FreeStyle Libre 2 CGM

The FreeStyle Libre 2 continuous glucose monitor (CGM). [Image from Abbott]Abbott (NYSE:ABT) announced today that a new study supports the use of its FreeStyle Libre 2 continuous glucose monitor (CGM).

The study, published in The New England Journal of Medicine, evaluated adults with type 1 diabetes and suboptimal glycemic control. It demonstrated significant reductions in glycated hemoglobin (HbA1c) compared to self-monitoring of blood glucose. Subjects sustained HbA1c reductions for the study duration of 24 weeks.

Abbott also reported links between FreeStyle Libre 2 and improvements in participant-reported quality of life outcomes. Those include overall satisfaction and reduction in burden associated with glucose monitoring.

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

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How should ketamine be used for depression? 

[Image courtesy of PubChem]

Proponents of ketamine for depression describe its remarkable ability to catalyze improvements in many patients’ mood disorders such as depression and anxiety.

However, the question of how the dissociative anesthetic ketamine should be used in the long-term to manage mood order symptoms is less clear.

Pharma efforts in ketamine for depression

First synthesized in 1962, ketamine’s patent expired in 2002. Janssen, however, managed to secure patent protection for Spravato, the S-enantiomer of ketamine that won FDA approval in 2019.

Janssen has not disclosed sales figures for its nasal spray-based Spravato, but GlobalData projects it will generate global sales of roughly $383 million by 2029.

Seelos Therapeutics, is developing intranasal racemic ketamine for acute suicidal ideation and behavior in patients with major depressive disorder (MDD). The company …

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Ipsen upgrading its Dublin manufacturing site

Ipsen opened its new manufacturing site in Blanchardstown in Dublin, Ireland last week following a €52 million investment.

Irish news outlet RTE reported the opening on Sept. 26. The report said the investment aims to upgrade and expand the existing facility’s capabilities.

The improved site features 175 employees, according to RTE. Ipsen’s Ireland R&D and manufacturing teams have scaled active pharmaceutical ingredient production by 10% year-over-year as a result of the facility’s improvements, the report said. Ipsen stated that the investment supported the “extension and acceleration of vital medicine production.”

Expansion in Ireland represents Ipsen’s recognition of the Irish market’s important role in its international network, the report said. Ipsen intends to continue growth as a provider of care across oncology, rare diseases and neuroscience.

“Ipsen is committed to continued investment a…

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Medtronic to install 115 GI Genius modules across VA facilities

Medtronic’s GI Genius intelligent endoscopy module. [Image courtesy of Medtronic]Medtronic (NYSE:MDT) announced today that its Gastrointestinal Business received a contract to install GI Genius systems at some Veterans Affairs (VA) facilities.

The contract comes through a partnership with a Service-Disabled Veteran-Owned Small Businesses (SDVOSB). Medtronic will install 115 GI Genius intelligent endoscopy modules across numerous VA medical facilities in the U.S.

Veterans can now access Medtronic’s artificial intelligence (AI) technology. The company designed it to improve the accuracy of polyp detection in colonoscopy screening. According to a news release, the Veteran’s Health Administration performs approximately 250,000 colonoscopies each year.

“We’re proud to give back to the men and women who have served our country by extending this powerful and proven tool in the fight against colorectal cancer,” said Geof…

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FDA clears 3D-printed titanium spacer from Life Spine

Life Spine announced today that it received FDA 510(k) clearance for its Ghost 3D-printed titanium spacer system.

Huntley, Illinois-based Life Spine’s Ghost 3D-printed titanium spacer expands on the company’s interbody portfolio. These implants include options for ALIF, PLIF/TLIF and lateral procedures. The 3D-printed titanium joins PEEK and titanium in the interbody portfolio.

Ghost spacers integrate porous surfaces designed to promote bony on-growth while maintaining external lattice geometry. Life Spine offers Ghost in a range of footprints and lordotic options to accommodate an array of patient anatomies and pathologies.

The system features streamlined instrumentation and Life Spine’s variety of posterior fixation offerings. These include the Avatar percutaneous screw system and the Nautilus spinal fixation system. Additionally, the company offers the Centerline midline screw system and ARx spinal fixation system.

Its endplat…

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Freudenberg Medical introduces HelixFlex TPE tubing

 HelixFlex TPE tubing [Image courtesy of Freudenberg Medical]

Freudenberg Medical this week announced the launch of its HelixFlex high-purity thermoplastic elastomer tubing.

The company says it designed the HelixFlex tubing for biopharmaceutical fluid transfer applications.

The expanded offering adds to Freudenberg’s existing pharma product portfolio of silicone tubing and components for bioprocessing, drug and vaccine manufacturing, filling and sampling, peristaltic pumping, lab, and medical device applications.

According to Freudenberg Medical, TPE tubing is ideal for pharmaceutical bioprocessing applications because it’s possible to weld it to existing tubing lines, heat sealing it to allow for easy, fast and safe fluid transport and transfer in biopharma processes.

It’s possible to sterilize Freudenberg’s TPE tubing through many methods, including autoclave, gamm…

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GSK shares positive headline results from Phase 2 study of dostarlimab with chemotherapy in non-small cell lung cancer

[Image courtesy of GSK]

GSK (LSE/NYSE:GSK) said that the PERLA Phase 2 study of dostarlimab met its endpoint of objective response rate in non-small cell lung cancer patients.

The study used Response Evaluation Criteria in Solid Tumors (RECIST) criteria to compare dostarlimab against Merck’s Keytruda (pembrolizumab) in patients with metastatic non-squamous non-small cell lung cancer who also received chemotherapy. A blinded independent central review evaluated the study’s results with RECIST v1.1 criteria.

AnaptysBio (Nasdaq:ANAB), a clinical-stage biotech, originally developed dostarlimab, which it later licensed to Tesaro, which GSK acquired in early 2019.

The randomized, double-blind PERLA study enrolled 243 patients.

GSK notes that the trial is the most extensive global head-to-head study of programmed death receptor-1 (PD-1) inhibitors in patients with metastatic non-squamou…

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Digital health funding hits a low

[Image from National Cancer Institute/Unsplash]Rock Health analysts say the third quarter of 2022 brought low funding numbers that raise questions about the condition of the digital health market.

The report tallies digital health funding at $2.2 billion across 125 deals in the third quarter. This represents the smallest funding quarter in the sector for all of 2022.

On top of that, it’s the lowest quarter by dollars raised in digital health since the fourth quarter of 2019 ($2.1 billion).  Overall funding took a freefall, dropping 48% between the second and third quarters.

Researcher Mihir Somaiya led the report with help from Adriana Krasniansky, Megan Zweig and Bill Evans. According to the researchers, 2022 year-to-date funding totals $12.6 billion across 458 deals. They now have doubts that the 2022 total can reach half of last year’s spoils of $29.2 billion.

There have been some big digital health deal announcements, though. Amazon m…

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What’s next for the medical device supply chain?

A host of medical device companies with manufacturing in Puerto Rico found their supply chains impacted by Hurricane Maria in 2017. It was a harbinger of what was to come. [Image is public domain]Recent hurricanes in Florida and Puerto Rico provide yet another reminder that the medical device supply chain remains vulnerable to climate change.

The COVID-19 pandemic presented its challenges. But as our sister Medical Design & Outsourcing site reported last year, expect superstorms, fires, droughts and other extreme events driven by climate change to continue to strain the supply chain.

Problems may even get worse.

Major medtech companies are taking steps to respond to the challenge. For example, Medtronic’s Supply Chain EVP Greg Smith overall has been driving changes with a team that is mostly new to the company. Medtronic has co-located over 100 Medtronic employees with top suppliers and worked directly with commodity and raw material suppliers, CE…

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Pfizer finalizes acquisition of Global Blood Therapeutics 

In August, Pfizer (NYSE:PFE) announced its plan to acquire Global Blood Therapeutics (GBT) for $68.50 per share, or roughly $5.4 billion.

Today, the company announced that it had finalized the acquisition, giving it access to GBT’s portfolio of drug candidates for sickle cell disease (SCD).

The GBT acquisition also adds Oxbryta (voxelotor), a novel sickle hemoglobin inhibitor, to its portfolio. Oxbryta has won marketing approval in the U.S., the European Union, United Arab Emirates, Oman and Great Britain.

In 2021, Oxbryta generated $194.7 million in sales, representing a 57% year-over-year increase.

GBT won Orphan Drug and Rare Disease designations from FDA for GBT021601 (GBT601) and inclaclumab, respectively.

Pfizer has developed therapies for rare hematologic diseases for three decades.

The company has been on a spending spree of late.

In March, Pfizer wrapped up a $6.7 billion acquisition of Arena Pharmaceuticals. Two mont…

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Atai Life Sciences launches Phase 1 study of buccal and IV synthetic DMT

Atai Life Sciences (Nasdaq:ATAI) has dosed the first patient in a Phase 1 single-ascending-dose study focused on VLS-01, a synthetic form of N,N-dimethyltryptamine (DMT) for treatment-resistant depression (TRD).

While many companies in the psychedelic industry first focused on psilocybin, a growing number of players are beginning to explore the therapeutic potential of DMT, a short-acting naturally-occurring psychedelic.

The active component of the South American psychedelic brew ayahuasca, DMT, is a 5-HT2A receptor agonist like psilocybin and LSD.

Unlike other classic psychedelics, DMT is not orally active when administered alone. Ayahuasca contains a monoamine oxidase inhibitor to protect DMT from metabolism.

The clinical-stage company Algernon Pharmaceuticals (CSE:AGN; Frankfurt:AGW0; OTCQB: AGNPF), for instance, has commenced a Phase 1 study of IV DMT in patients ischemic stroke patients.

Although treatment-resistant depression lacks a …

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Study supports SpineX neuromod system for treating children with cerebral palsy

[Image from SpineX]SpineX announced today that its first-in-human study backs the use of its proprietary non-surgical treatment for children with cerebral palsy (CP).

Los Angeles-based SpineX published the study in Nature Communications. Dr. Susan Hastings and Dr. V Reggie Edgerton led the study.

SCiP demonstrated unparalleled functional improvements with SCiP (spinal cord innovation in pediatrics) in children with CP. The study combined non-invasive spinal neuromodulation and activity-based neurorehabilitation therapy, SpineX said in a news release.

SpineX said SCiP delivery during physical therapy improved sensorimotor function in 16 of 16 children. This patient population included a wide range of ages and CP severity. The treatment holds breakthrough device designation from the FDA. The company plans to align with the agency for a proposed clinical trial for 2023. It plans to use the results to pursue FDA clearance for SCiP in the treatment of CP.

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Nevro wins FDA approval for manufacturing operations in Costa Rica

[Image courtesy of Google Maps]Nevro (NYSE:NVRO) announced that the FDA approved manufacturing operations in Costa Rica for the production of its spinal cord stimulation (SCS) systems.

Redwood City, Californa-based Nevro’s new facility sits in the Coyol Free Trade Zone in Alajuela, Costa Rica. It produces proprietary SCS systems that treat chronic pain, including the HFX product platform.

The facility represents the company’s first global manufacturing operation. Nevro said this ensures greater controls and efficiency while augmenting manufacturing nad supply chain partners.

“We are pleased that the FDA has approved our new global manufacturing operations in Costa Rica,” said D. Keith Grossman, chair, CEO and president of Nevro.  “As part of our growth plans moving forward, this manufacturing facility will support our pipeline of future products to ensure that we have the most efficient cost structure and flexible capacity, whi…

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FDA clears sacroiliac joint fixation system from Aurora Spine

Aurora Spine (OTCQB:ASAPF) announced that it received FDA 510(k) clearance for its SiLO TFX MIS sacroiliac joint fixation system.

In a news release, the company described SiLo TFX MIS as a patented and minimally invasive system.

Carlsbad, California-based Aurora Spine said it plans to disclose additional details regarding the system tomorrow, Oct. 6, 2022. This story may be updated.

 

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Fresenius Kabi launches gadoterate meglumine injection

Fresenius Kabi has begun selling gadoterate meglumine injection, USP, a bioequivalent and therapeutic equivalent substitute for Guerbet’s contrast agent Dotarem.

The product launch is the second contrast agent Fresenius Kabi has introduced in the U.S. this year. The Kale Zurich, Illinois–based company launched iodixanol injection, USP, in July during a nationwide shortage.

Radiologists use contrast agents to enhance the visibility of internal structures in imaging procedures such as MRI or CT scans. Contrast agents are a new category of health care products for Fresenius Kabi.

“Fresenius Kabi is pleased to expand our contrast agent portfolio and our support for the radiology community with the launch of gadoterate meglumine injection, USP,” said John Ducker, president and CEO of Fresenius Kabi USA, in a news release. “Contrast agents are vital to patient diagnosis, and the addition of Fresenius Kabi gadoterate meglumine will provi…

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DMT pioneer Rick Strassman weighs in psychedelic hope and hype

[Image courtesy of PubChem]

Interest in the therapeutic potential of psychedelics may have exploded in recent years, but the field will likely see “a lot of separating the wheat from the chaff,” said Dr. Rick Strassman, a professor at the University of New Mexico School of Medicine and author of “DMT: The Spirit Molecule” and “The Psychedelic Handbook.”

In the 1990s, Strassman conducted pioneering research on the psychedelic DMT (N,N-dimethyltryptamine), which is found in many plants and animals.

While the number of psychedelic companies has exploded recently, the herd may already be thinning. Several public companies in the space have seen their valuations plummet over the past year.

“I think there’ll be more consolidation,” Strassman predicted. “There will be just a handful of players in the end.”

Strassman recommends that c…

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Avania Analytics Platform Bypasses Unstable Internet

No connection? No problem! A research team was looking to utilize a real-time EDC system inside ORs and ICUs with little to no internet access. It takes practical insight, a custom-designed database, and an innovative eCRF to build a seamless solution. It Takes Avania.

View the Case Study via the form below.

 

 

 

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Bringing motion to medicine: How Actuated Medical is innovating deep brain stimulation and more

Actuated Medical co-founder, President and CEO Maureen Mulvihill [Photo courtesy of Actuated Medical]

Actuated Medical is making electrode placement for deep brain stimulation easier and less traumatic.

Nearly 16 years ago, Actuated Medical co-founder, President and CEO Maureen Mulvihill was working for a company making actuators that were the size of a grain of rice. While the company was focused on components, she wanted to help patients more.

“I was actually sitting in a doctor’s office and I was showing him the little actuators. He’s like, ‘Maureen, I don’t need that. I need the whole system FDA approved,'” she told Medical Design & Outsourcing.

Mulvihill understood that sentiment and went on to start Actuated Medical with the idea of putting motion into medicine.

Bellefonte, Pennsylvania-based Actuated Medical is a medical device product developmen…

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