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Alva Health stroke monitor wins MedTech Innovator startup prize

Alva Health’s stroke monitor [Photo courtesy of Alva Health]

MedTech Innovator has awarded its $350,000 global startup competition grand prize to Alva Health.

Alva Health has developed a wearable, real-time stroke monitor. The New Haven, Connecticut-based startup won the medical device accelerator competition after a Wednesday vote by attendees of The MedTech Conference, organized by AdvaMed.

“Alva Health’s mission is to develop, commercialize and make accessible a first-in-class medical device that accurately detects strokes using patient-worn wearables,” Alva Health co-founder and CEO Sandra Saldana said in a news release. “This award represents a recognition of the tremendous clinical unmet need for patients, and an important milestone in Alva Health’s journey. We are grateful to the MedTech Innovator community for their support and for the opportunity to receive mentorship fro…

Why is the vaccination rate in the U.S. stalling?

Image courtesy of Pexels

In a recent press briefing, White House press secretary Jen Psaki touched on the flatlining COVID-19 vaccination rates in the U.S.

Despite a series of vaccine mandates, the daily rate of new COVID-19 vaccinations is the lowest it’s been since mid-January, according to CDC data.

Daily U.S. vaccination rates have returned dipped below 500,000 doses per day, which had been a lower threshold in July.

“We did expect that rates of newly vaccinated would decline over time as they have in other countries with more mature vaccination programs,” Psaki said.

Jen Psaki. Image courtesy of Wikipedia.

There have also been similar declines in vaccination rates in countries with advanced vaccination programs. Examples include the United Kingdom, Israel and Canada. “As a greater percentage of the population is vacci…

FDA could support 50-µg booster dose of Moderna vaccine

The FDA could authorize the use of Moderna (NSDQ:MRNA) COVID-19 vaccine boosters at a half-dose level, according to a report from Bloomberg.

Each primary series dose of the Moderna vaccine contains 100 µg of mRNA. By contrast, the Pfizer-BioNTech vaccine uses a 30-µg dose level for the primary series and boosters.

Earlier this month, Moderna CEO Stéphane Bancel said that recent data from its Phase 3 COVD study “supports the need for a booster to maintain high levels of protection.”

E.U. authorities are also reviewing data related to booster doses of the Moderna vaccine.

In addition, the European Medicines Agency is considering authorizing a booster dose of the Pfizer-BioNTech vaccine. The agency said it hopes to announce its decision in early October.

NIAID Director Dr. Anthony Fauci ultimately predicts that regulatory authorities will view mRNA vaccines as requiring three doses.

While U.S. authorities now recommend matching boosters…

ProMation Engineering taps Tom Wayer as national sales manager

Electrical actuator and flow-control firm ProMation Engineering has hired Tom Wayer as a national sales manager.

The company can provide custom flow-control products to meet customer-specific needs for various industries, including pharmaceutical manufacturers.

Brooksville, Florida–based ProMation also serves the chemical processing industry.

Wayer has experience selling equipment, systems and entire projects with actuators, valves, pumps, sensors, dampers and piping.

“I am excited to be able to join ProMation Engineering,” Wayer said. “I feel like I have a substantial leg up in understanding ProMation’s business since I have been not only selling similar products but purchasing, installing and troubleshooting control equipment as a contractor and installer.”

Honeywell acquires MES firm Performix

Honeywell (NASDAQ:HON) will integrate manufacturing execution system (MES) software offerings from Performix Inc. into its portfolio of offerings for life science companies.

Financial details of the transaction were not disclosed.

Houston, Texas–based Performix specialized in creating MES software for pharma and biotech companies.

Late last year, Honeywell announced its intent to acquire privately-held Sparta Systems (Atlanta), a provider of quality management software, for $1.3 billion.

Honeywell’s life sciences strategy is to offer a comprehensive software suite that can integrate multiple systems into a single manufacturing ecosystem, according to Ujjwal Kumar, president of Honeywell Process Solutions. “Honeywell can now offer customers a tailored solution designed for their specific industry that combines process automation, production management, quality management and data analytics into a single software suite,” he said in a statement.

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Schott Minifab has a deal to buy Applied Microarrays Inc.

[Photo courtesy of Schott Minifab]

Schott subsidiary Schott Minifab on Tuesday said it has negotiated the purchase of Applied Microarrays Inc. (AMI)

Australia-based Schott Minifab, which develops and manufactures microfluidic devices for point-of-care and life sciences consumables, has worked with AMI to develop biotech substrates for diagnostics applications.

The deal, expected to close in early October, expands Schott Minifab’s biosensor printing capabilities as demand grows for point-of-care microarray consumables for applications such as infectious disease testing. Tempe, Arizona-based AMI will soon move to a larger facility in the Phoenix area.

“We pride ourselves on being an end-to-end partner for the global diagnostics industry,” said Greg Wolters, head of Schott Minifab, in a news release. “Our expansive offering allows us to provide an integrated single-source collection of value-intensiv…

GE Healthcare unveils next-gen cardiac-dedicated nuclear scanner

GE Healthcare (NYSE:GE) today announced that it has launched its MyoSpect cardiac-dedicated nuclear scanner.

Chicago-based GE Healthcare designed the scanner to have an extended field-of-view processing with a new automated workflow. It features the company’s Alcyone technology and a CZT module design for a view of cardiac anatomy and pathology.

“Today, the need for healthcare innovation is stronger than ever,” Jean-Luc Procaccini, president and CEO of GE Healthcare’s molecular imaging and computed tomography, said in a news release. “Not only is demand for nuclear cardiac solutions increasing, but new and tough cardiac cases require a different approach to patient comfort, image quality, and workflow. That’s why we designed MyoSpect with all these factors in mind. Not only does MyoSpect offer extended field of view processing to help accommodate a greater variety of patients, but its digital CZT detectors and new automated workflow features also he…

Henry Schein promotes top lawyers

Walter Siegel [Photo courtesy of Henry Schein]Henry Schein (Nasdaq: HSIC) has promoted four members of its legal team to high-ranking positions.

The medical device manufacturer and distributor on Monday named SVP Walter Siegel as chief legal officer, Kelly Murphy as SVP and general counsel, Jennifer Ferrero as deputy secretary and Reid Arstark to senior counsel, mergers & acquisitions.

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

Janssen begins Phase 3 study for RSV vaccine in adults 60 and older

After recently sharing positive Phase 2b data related to its experimental respiratory syncytial virus (RSV) vaccine in seniors, Janssen (NYSE: JNJ) has launched a Phase 3 study of the vaccine.

RSV is common and contributes to serious respiratory illnesses, including pneumonia in the elderly. The virus infects approximately 64 million people annually.

The global EVERGREEN study will enroll roughly 23,000 adults 60 years of age and older.

“Positive data from our first RSV vaccine efficacy study and the initiation of the Phase 3 EVERGREEN study are crucial milestones in the clinical development of our investigational RSV adult vaccine, which has the potential to safely and effectively prevent lower respiratory tract disease caused by RSV in older adults,” said Dr. Penny Heaton, global therapeutic area head, vaccines at Janssen Research & Development.

Currently, no vaccines are available for RSV, although several are in development.

FD…

Henry Schein promotes top lawyers

Henry Schein (Nasdaq: HSIC) has promoted four members of its legal team to high-ranking positions.

Walter Siegel [Photo courtesy of Henry Schein]

The medical device manufacturer and distributor on Monday named SVP Walter Siegel as chief legal officer, Kelly Murphy as SVP and general counsel, Jennifer Ferrero as deputy secretary and Reid Arstark to senior counsel, mergers & acquisitions.

“Walter quickly distinguished himself throughout the Company with his integrity, legal acumen, strategic thinking, and leadership skills,” Henry Schein CEO and Board Chair Stanley Bergman said in a news release. “Walter’s new role reflects the increasing global complexity of the laws, rules, and regulations that multi-national companies must navigate. We are pleased to have Walter in this expanded role.”

Kelly Murphy [Photo courtesy of Henry Schein]

Sieg…

AbbVie’s migraine drug Qulipta wins FDA nod as a preventive migraine treatment

Qulipta (atogepant) from AbbVie (NYSE:ABBV) has become the first calcitonin gene-related peptide (CGRP) agonist to win FDA approval for the preventive treatment of migraine headaches.

In recent years, the agency has approved two related drugs, Ubrelvy (ubrogepant) from AbbVie subsidiary Allergan (NYSE:ABBV) and Nurtec ODT (rimegepant sulfate) from Biohaven Pharmaceutical Holding Company Ltd. (NYSE:BHVN). Both of those products are indicated for the acute treatment of migraines with or without aura.

North Chicago–based AbbVie published results from the pivotal ADVANCE study in The New England Journal of Medicine.

Qulipta bottle image courtesy of AbbVie

Participants in the trial had a mean number of monthly migraine days ranging from 7.5 to 7.9. Recipients of 10-mg atogepant saw an average reduction of 3.7 days in migraine days per month. For the sake of comparison, recipients of 30-mg atogepant …

AdvaMed honors former BD CEO Ludwig with its Lifetime Achievement Award

Former BD CEO Edward Ludwig

AdvaMed this week honored former BD CEO Edward Ludwig with its 2021 AdvaMed Lifetime Achievement Award.

Ludwig received the award on September 27 during an in-person and live-streamed event as part of The MedTech Conference.

Ludwig joined BD in 1979 and rose through the ranks to eventually become chair and CEO, retiring from the company in 2012.

AdvaMed in a news release praised the leadership that Ludwig demonstrated at BD:

He was instrumental in bringing the BD BACTEC 9000 system to market, a family of continuous blood monitoring and blood culturing instruments, revolutionizing the way blood culturing was performed, ultimately improving patient care and safety for health care workers.

With the goal of developing current and future leaders in the company, Ludwig established BD University, a management-driven leadership development program within the company. At BD, everyone who worked with him could tell you abo…