- Medical Design Sourcing

CDC’s Advisory Committee on Immunization Practices (ACIP) has recommended the Janssen (NYSE:JNJ) COVID-19 vaccine booster at least two months after the initial dose.

The committee also recommended a booster of the Moderna’s (NSDQ:MRNA) COVID-19 vaccine for people 65 and a handful of other demographics. Also eligible for boosters are individuals at least 18 who are immunocompromised and those who have frequent occupational or institutional exposure to SARS-CoV-2.

The recommendation for the Moderna boosters pertains to the 50-µg dose level, which is half the level used in the primary series.

CDC Director Dr. Rochelle Walensky will now decide whether to accept or alter the ACIP recommendations. For the Pfizer-BioNTech booster, Walensky opted to support boosters for a larger segment of people than the ACIP had recommended.

Walensky is likely to issue a final decision in the coming days.

The CDC advisors also recommended allowing Americans to ch…

Novartis to continue manufacturing Pfizer/BioNTech vaccine

Novartis (NYSE:NVS) has announced that it has reached an agreement with BioNTech (NSDQ:BNTX) and Pfizer (NYSE:PFE) to produce their popular COVID-19 BNT162b2 vaccine.

The companies reached a new production agreement that will leave Novartis responsible for fill-and-finish operations related to the mRNA-based vaccine from Pfizer and BioNTech.

Under the agreement, Novartis will produce at least 24 million doses of the vaccine in 2022 in its facilities in Ljubljana, Slovenia.

This year, Novartis had an agreement for the fill and finish of more than 50 million doses.

For the agreement pertaining to 2022, Novartis intends to obtain bulk mRNA from BioNTech to fill into vials under sterile conditions. The company will return the vaccine doses to BioNTech for distribution.

In related news, Pfizer recently announced data from a Phase 3 study, which found that a booster dose of its vaccine was 95.6% effective against COVID-19 in a period when the Del…

Study finds single-use bronchoscopes reduce hospital readmission rates by half

The Ambu aScope4 single-use bronchoscope [Photo courtesy of Ambu]A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half.

The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities.

He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days, compared to 7.7 percent of patients whose procedures used reusable scopes.

Get the full story at our sister site, Medical Design & Outsourcing.

Study finds single-use bronchoscopes reduce hospital readmission rates by half

The Ambu aScope4 single-use bronchoscope [Photo courtesy of Ambu]

A study of 14,228 bronchoscopy procedures found sterile, disposable scopes reduced readmission rates by more than half.

The study, authored by Ambu consultant Dr. Hudson Garrett, analyzed procedures at inpatient hospitals as well as outpatient ambulatory facilities.

He found that 3.6 percent of patients treated with a single-use, flexible bronchoscope were readmitted within 30 days, compared to 7.7 percent of patients whose procedures used reusable scopes.

“The data analysis demonstrates significant clinical benefits of single-use bronchoscopes in reducing readmission rates and patient risk,” Garrett said in an Ambu news release. “To reduce these risks, the use of sterile single-use bronchoscopes should be considered to eliminate reprocessing failures, improve overall operational efficiency and reduce potential acquisition of healt…

Torx Software bolsters web-based platform for small-molecule drug discovery

Privately-held Torx Software Ltd has expanded its software platform offerings with an automated assay scheduling tool known as Torx Test and compound analysis tool Torx Analyze.

Torx offers an internet platform that supports collaboration, knowledge sharing and resource management. In addition, Design-Make-Test-Analyze (DMTA) workflow functionality supports resource management and progress tracking.

Torx Test allows chemists and assay scientists to collaborate on scheduling, management and delivery of results related to various assays. In addition, the tool extends the molecule tracking capability of the company’s Torx Make software, enabling users to monitor the test status of compounds across multiple workflows.

Torx Analyze offers 2D and 3D analysis of molecule data imported from corporate databases. In addition, the software integrates with the company’s information sharing and molecule design capabilities tool known as Torx Design.

“Torx conn…

Medtronic hires social-media-minded chief medical officer for its gastrointestinal unit

Dr. Austin Chiang is chief medical officer of Medtronic’s Gastrointestinal business [Photo courtesy of Medtronic]

Medtronic (NYSE:MDT) today said it has hired Dr. Austin Chiang as the first chief medical officer of the medical device maker’s gastrointestinal business.

Chiang is an assistant professor of medicine at Sidney Kimmel Medical College and director of the Endoscopic Bariatric Program at Thomas Jefferson University Hospital, both in Philadelphia. He holds a master’s degree in public health from the Harvard T.H. Chan School of Public Health.

“I am thrilled to be joining Medtronic at such an innovative time in healthcare and especially in the gastrointestinal space, helping to deliver on what is a promising future for those in need of innovative GI care around the world,” Chiang said in a news release. “I look forward to joining a world-renowned team of brilliant engin…

Boston Scientific settles patent dispute with Micro-Tech Endoscopy over hemostasis clips

Micro-Tech SureClip

Boston Scientific (NYSE:BSX) said yesterday that it has resolved its patent infringement litigation against Micro-Tech Endoscopy over hemostasis clips used in endoscopy procedures.

The clips are applied to tissue or blood vessels to stop gastrointestinal bleeding.

Get the full story on our sister site, Medical Design & Outsourcing.

Boston Scientific settles patent dispute with Micro-Tech Endoscopy over hemostasis clips

Micro-Tech’s SureClip

Boston Scientific (NYSE:BSX) said yesterday that it has resolved its patent infringement litigation against Micro-Tech Endoscopy over hemostasis clips used in endoscopy procedures.

Boston Scientific said it will grant a five-year, royalty-bearing license to Ann-Arbor, Mich.-based Micro-Tech for the patented hemostasis clip technology. The clips are applied to tissue or blood vessels to stop gastrointestinal bleeding.

In exchange, Micro-Tech agreed to drop its patent validity challenges, Marlborough, Massachusetts-based Boston Scientific said.

“The settlement resolves all worldwide litigation between the companies,” Boston Scientific said in a news release.

Boston Scientific sued not only Micro-Tech, but also Chinese manufacturer Micro-Tech Nanjing and distributor Henry Schein. Boston Scientific’s lawsuit — filed in U.S. District Court in Delaware — claimed th…

Danaher slides despite Street-beating Q3

Danaher (NYSE:DHR) shares dipped today even as the company registered third-quarter results that topped the consensus forecast.

The Washington, D.C.-based company posted profits of $1.2 billion, or $1.54 per share, on sales of $7.2 billion for the three months ended Sept. 30, 2021, for a 31.1% bottom-line gain on sales growth of 22.9%.

Adjusted to exclude one-time items, earnings per share were $2.39, 24¢ ahead of Wall Street, where analysts were looking for sales of $7 billion.

“Our team delivered another outstanding result in the third quarter, with over 20% core revenue growth and terrific earnings and cash flow performance. We continued to invest for growth across our businesses, expanding production capacity and accelerating innovation initiatives,” Danaher President & CEO Rainer M. Blair said in a news release. “Additionally, the recently closed acquisition of Aldevron enhances our portfolio and expands our capabilities into …

How vapor degreasing is helping to future-proof medical device reliability

The demand for digital wellness means an increasing need for small, complex electronic components. [Image courtesy of MicroCare]

Precision cleaning of electronic medical devices boosts reliability.

Jay Tourigny, MicroCare

COVID-19 has brought the importance of wearable and remote monitoring and diagnostic devices to the forefront. But these devices, with their intricate PCBAs (printed circuit board assemblies) must deliver reliable and consistent performance, particularly as they are often used in devices that are life-sustaining.

Cleaning is a key contributor to PCBA performance consistency and should be factored in when designing complex and multifaceted electronics. What cleaning processes should be adopted and how do you ensure cleanliness standards are met?

Why is reliability important?

The medical electronics market is estimated to be worth $6.3 billion in 2021 and projected to reach $8.…

ACIP votes unanimously backs GSK’s shingles vaccine Shingrix for immunocompromised adults 19 and older

CDC’s Advisory Committee on Immunization Practices (ACIP) unanimously recommended two doses of GlaxoSmithKline’s (NYSE:GSK) Shingrix (a recombinant adjuvanted zoster vaccine) for adults 19 and older with immunodeficiency or immunosuppression as a result of disease or therapy.

CDC considers Shingrix to be an adult vaccine, and its recommendation is for the adult immunization schedule, which begins at the age of 19.

In addition, ACIP was unanimous in backing Merck’s (NYSE:MRK) and Pfizer’s (NYSE:PFE) pneumococcal vaccines in elderly and immunocompromised adults.

ACIP will share the recommendations with the director of the CDC and the US Department of Health and Human Services for review and approval.

Shingrix first won FDA approval in 2017 to prevent shingles in adults aged 50 and older. In July of this year, the agency extended approval to include adults aged 18 and older with an elevated risk of developing shingles as a result of immunodeficiency …

Eli Lilly touts data for tirzepatide compared to insulin glargine for type 2 diabetes

Eli Lilly (NYSE:LLY) announced positive results from a trial comparing tirzepatide to titrated insulin glargine in adults with type 2 diabetes.

Indianapolis-based Eli Lilly’s Surpass-4 clinical trial demonstrated that adults with type 2 diabetes and increased cardiovascular (CV) risk experienced superior A1C and body weight reductions from baseline across all three doses of tirzepatide compared to titrated insulin glargine.

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

DarioHealth unveils digital therapy for treating musculoskeletal conditions

DarioHealth (NSDQ:DRIO) announced that it launched Dario Move, a digital physical therapy platform for musculoskeletal (MSK) conditions.

With the introduction of the Dario Move, Boston-based Dario adds to its suite of chronic condition management platforms that include treatments for diabetes, behavioral health and metabolic health, according to a news release.

Dario Move combines software, technology and professional human support with features including a single biofeedback sensor for ease of use, personalized evidence-based exercise programs designed by physical therapists, real-time feedback and support and a highly personalized experience across Dario’s full suite of chronic condition solutions.

“The launch of Dario Move marks a significant achievement for our company, as we successfully and efficiently integrated the Upright MSK solution into our comprehensive multi-chronic condition digital therapeutics platform, further expanding its …

J&J Institute, DePuy Synthes launch mobile training lab for Velys robotic surgery platform

Image from Depuy Synthes/Johnson & Johnson

DePuy Synthes and the Johnson & Johnson Institute launched a mobile training lab for surgeons using the Velys robot-assisted platform.

The first-of-its-kind mobile training lab offering next-generation training directly to surgeons and their teams was launched in Sydney, Australia, according to a news release.

DePuy Synthes, the orthopaedics business unit of Johnson & Johnson, will offer on-site access to the training along with virtual reality-based operating environments and real-time collaboration at the Velys Digital Surgery Mobile Lab. All of the offerings intend to equip Australian orthopaedic surgeons with the capabilities to proficiently use the Velys robotic-assisted solution.

Velys, a first-of-its kind, table-mounted solution offers an efficient design capable of integrating into any operating room, the company said. DePuy said it adapts to a surgeon’s workflow, offers control they are used…

Why FDA optimized for flexibility with COVID-19 vaccine booster choice

Early data seem to suggest that mRNA vaccine boosters are more effective than additional doses of the adenovirus-vector COVID-19 vaccines from AstraZeneca and Johnson & Johnson.

But scientists don’t currently have “any real clinical effectiveness data on this question,” said Dr. Janet Woodcock, acting FDA commissioner.

To date, vaccine developers have heavily relied on antibody response data to measure the immune response additional vaccine doses offer.

“We really don’t know the connection between [antibody response data] and actually how well protected somebody is,” Woodcock said.

Further complicating matters is the fact that such antibody levels are a measure of a short-term immune response, said Dr. Peter Marks, director of the Center for Biologics Evaluation and Research (CBER) at FDA.

“That’s not to discourage people from getting these boosters,” Marks said.

But scientists have comparatively little data on T cell…

Why COVID-19 booster criteria will remain complicated for now

The FDA has authorized COVID-19 vaccine boosters for many people who are fully vaccinated.

Individuals seeking boosters must currently navigate a sort of checklist to confirm their eligibility.

The criteria for the Janssen vaccine are the simplest: Anyone who has received a single dose of that vaccine can receive an additional dose two months or more after the first.

The Pfizer-BioNTech and Moderna boosters are available to fully vaccinated people 65 or older, provided six months have elapsed after receipt of the last dose. In addition, individuals 18 and older who live in a long-term care facility are also eligible. Those who live or work in high-risk settings also can get the shot, as can individuals with certain medical conditions.

When asked when FDA would authorize boosters to all individuals 18 and older, Dr. Peter Marks, a senior official at FDA, said in a media briefing, “I think we may get…

White House reveals plan to vaccinate children aged 5 to 11

Photo by Aaron Kittredge from Pexels

The White House says that vaccination will be readily available and free of charge for children between the ages of five and 11, assuming the FDA and CDC authorize them.

The authorization of a vaccine for that age group would make 28 million additional Americans eligible for vaccination.

Pfizer recently asked FDA to extend emergency use authorization (EUA) to its vaccine, which it jointly developed with BioNTech.

An FDA advisory committee will convene on October 26 to discuss Pfizer’s request to amend the EUA. While some members of the Vaccines and Related Biological Products Advisory Committee (VRBPAC) have signaled concern about the risk of myocarditis linked to mRNA vaccines in children in the past, clinical trial data suggest the vaccines are safe and effective in five- to eleven-year-olds.

The White House said it would begin dispensing shots with…

Freudenberg Medical launches SpeakFree HME valve for laryngectomy care

The SpeakFree HME hands free valve [Photo courtesy of Freudenberg Medical]

Freudenberg Medical today announced the commercial launch of its Blom-Singer SpeakFree heat and moisture exchange (HME) hands free valve.

The device is designed for people who have undergone a total laryngectomy, or the removal of a person’s larynx or voice box, resulting in loss of speech.

Carpinteria, California-based Freudenberg Medical’s InHealth Technologies unit said its SpeakFree HME is the first single-use HME cartridge with an adjustable valve that does not require manual closure to speak, enabling hands-free speech for individuals with a tracheoesophageal puncture and voice prosthesis. The daily disposable product is adjustable for an individual’s activity and offers flexibility of hands-free and digital occlusion.

“This product is a game-changer and demonstrates InHealth’s commitment to ongoing innova…

Luminopia’s new FDA-approved therapy uses TV to treat lazy eye in kids

Luminopia announced today that it received FDA de novo approval for its prescription therapy for improving vision in children with lazy eye.

Cambridge, Massachusetts-based Luminopia’s prescription Luminopia One holds indication for improvement in visual acuity in children between ages four and seven with lazy eye (amblyopia) associated with anisometropia and/or mild strabismus, having received treatment instructions as prescribed by a trained eye-care professional, according to a news release.

Get the full story at our sister site, Medical Design & Outsourcing.

Luminopia’s new FDA-approved therapy uses TV to treat lazy eye in kids

Luminopia announced today that it received FDA de novo approval for its prescription therapy for improving vision in children with lazy eye.

“The FDA approval of a new digital therapy with robust clinical evidence for children affected by amblyopia is a major development. Amblyopia is one of the most common conditions I manage as a clinician, and patients, parents and physicians often struggle with current therapies,” Boston Children’s Hospital Ophthalmologist-in-Chief & Richard Robb Chair in Opthalmology & advisor to Luminopia Dr. David G. Hunte said in the release. “The idea of prescribin…

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