FDA OKs Pfizer-BioNTech COVID-19 vaccine for younger adolescents

The FDA has authorized the COVID-19 vaccine from Pfizer (NYSE:PFE) and BioNTech (NSDQ:BNTX) for adolescents as young as 12. The agency had previously authorized the vaccine for people 16 and older in December 2020.

The FDA came to its decision after Pfizer demonstrated in a Phase 3 trial that the vaccine showed 100% efficacy in preventing symptomatic COVID-19. The vaccine also had favorable reactogenicity in 12- to 15-year-olds in the study involving 2,260 participants.

“Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,” wrote Acting FDA Commissioner Janet Woodcock, MD, in prepared remarks. “Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations.”

An advisory committee of the Centers for Disease Control and Pr…

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BWXT Medical to make TheraSphere microspheres for Boston Scientific

BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere.

Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company.

Get the full story at our sister site, MassDevice.

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New ethylene oxide regulations now expected in 2022

(Image from the U.S. Occupational Safety and Health Administration)

The EPA now estimates that it will issue propose new regulations for medical device sterilizers’ emissions of ethylene oxide (EtO) in 2022.

The agency issued an advance notice of proposed rulemaking for the commercial sterilizers in December 2019 but has not produced the proposal.

Now the EPA’s inspector general wants the agency to conduct a new residual risk and technology review for commercial and industrial sites that use or produce EtO, particularly because some of these facilities are located in areas populated by people of color or low income.

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

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Transit Scientific scoring sheath wins CE mark

Transit Scientific today said it received CE mark clearance for its XO Score scoring sheath platform.

XO Score is designed for dilation of stenotic material in the peripheral vasculature, including popliteal, infrapopliteal and native or synthetic arteriovenous dialysis fistulae.

The scoring and cutting technology in the device enables low-pressure lesion dilation and vessel prep with standard off-the-shelf PTA balloons. The sheaths can deliver enhanced angioplasty with basic balloons.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Bigfoot Biomedical wins FDA clearance for smart insulin pen cap system

[Image from Bigfoot Biomedical]Bigfoot Biomedical announced today that it received FDA 510(k) clearance for its Bigfoot Unity diabetes management system.

Milpitas, Calif.-based Bigfoot’s first-of-its-kind Bigfoot Unity system features connected smart pen caps designed to recommend insulin doses for diabetes patients using multiple daily injection (MDI) therapy, according to a news release.

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

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BWXT Medical, Boston Scientific forge agreement to manufacture TheraSphere microspheres

BWXT Medical announced today that it entered into a long-term, mutually exclusive agreement to manufacture Boston Scientific’s TheraSphere.

Ottawa, Ontario-based BWXT’s new deal with Boston Scientific covers manufacturing of the TheraSphere Y-90 glass microspheres from the Marlborough, Mass.-based medtech company.

TheraSphere treatment for patients with hepatocellular carcinoma (HCC) delivers millions of glass microspheres containing radioactive Yttrium-90 directly to liver tumors through a catheter with minimal exposure to surrounding healthy tissue, according to a news release.

Under the agreement, BWXT Medical, a subsidiary of BWX Technologies, will invest to automate the manufacturing process at its Ottawa facility in an effort to increase capacity and dependability to match the growing global demand for TheraSphere.

“We congratulate Boston Scientific on its recent receipt of FDA PMA approval of TheraSphere, which expands patient a…

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FDA clears Olympus airway mobilescopes

Olympus (TYO:7733) today said it received FDA clearance for its line of airway mobilescopes.

The mobilescopes enable physicians to perform a broad range of upper and lower airway management procedures.

“We are proud to present to the market the only flexible mobilescope models with a video camera on the tip,” Lynn Ray, VP and GM of global respiratory at Olympus, said.

Get the full story on our sister site, Medical Tubing + Extrusion.

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Medical Wearables Solution Guide

Boyd has leveraged decades of experience to develop a quick Guide to Engineered Materials and Thermal Solutions for optimized Medical Wearables. This guide covers technologies necessary to protect, seal, and cool these small, but vital devices while improving reliability, connectivity, accuracy, and user safety. The article also highlights how to best utilize these technologies to reduce weight and landed costs, as well as streamline the supply chain for the full spectrum of Medical Devices.

Download this guide…

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MedTech 100 roundup: Largest slide for industry in 2021

The medtech industry’s 2021 performance has been all over the place and the past weekend highlighted its topsy-turvy nature.

MassDevice‘s MedTech 100 Index — which includes stocks of the world’s largest medical device companies — had been on the rise since the beginning of April, with its mark of 112.25 on April 16 representing an all-time best, topping the previous high of 110.96 set on Feb. 15.

Just one week later, the index topped itself again, reaching 114.58 to end the week on April 23, marking an increase of 2.1% from the previous week.

After a -1.6% decrease over the week ending on April 30, there was little indication of in which direction the index would head next. The industry’s response to the slight dip was an even sharper downturn with a 4.49-point loss.

On May 6, the index finished the day at 108.21, representing a -4% slide from the previous week’s mark and a -5.6% fall from the high-point set the previous week. Th…

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Improving vaccine production with advanced analytics

mRNA vaccine picture courtesy of Wikipedia

This scientific, engineering and logistical achievement that is the COVID-19 vaccine is a feat unparalleled. It’s the perfect example of human ingenuity and how modern advancements can make a difference. A lot of credit, however, has to go to the rise of Industry 4.0 and the use of digital technologies like automation, computer science, and advanced analytics. In fact, automated operations, process simulation, and self-service analytics have helped pharmaceutical production processes become more agile and efficient, contributing to increased production capacity and product quality. This solution has become the production and quality control game-changer by making pharmaceutical companies more adaptive and responsive, thus improving operational processes.

Using time-series data to improve operational performance

Captured from sensors throughout the production line, t…

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Axonics rises on mixed-bag Q1 results

Axonics (NSDQ:AXNX) posted first-quarter results yesterday that beat the revenue consensus on Wall Street but missed on earnings projections.

The Irvine, Calif.-based company reported losses of -$22.5 million, or -57¢ per share, on sales of $34.4 million for the three months ended March 31, for a sales growth of 30.72% compared with Q1 2020.

Earnings per share were -57¢, 16¢ behind The Street, where analysts were looking for sales of $27.88 million.

“This quarter’s revenue result reflects the growing demand for our long-lived r-SNM system and Bulkamid despite the resurgence of COVID cases in the U.S. in early 2021 and ongoing lockdowns in Europe,” CEO Raymond Cohen said in a news release. “Physician and patient satisfaction remain high and Axonics is poised to take full advantage of the strong growth outlook for sacral neuromodulation as the vaccine rollout continues and we return to a more normalized elective procedure environment.”

“Response to …

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Cardiovascular Systems sinks on missed Q3 earnings projections

Cardiovascular Systems (NSDQ:CSII) posted third-quarter results yesterday that beat the revenue consensus on Wall Street but missed on earnings projections.

The St. Paul, Minn.-based company reported losses of -$6 million, or -15¢ per share, on sales of $63.27 million for the three months ended March 31, for a sales growth of 3.43% compared with Q1 2020.

Earnings per share were -15¢, 4¢ behind The Street, where analysts were looking for sales of $63.18 million.

“We finished the third quarter on a strong note. The increase in vaccinations and a simultaneous decrease in Covid hospitalizations in February and March resulted in improved procedure volumes during the second half of the quarter,” president and CEO Scott Ward said in a news release. “Third-quarter revenues increased 3.4% to $63.3 million and were led by our coronary franchise, due to strong procedure volume domestically, increased sales of procedure support products, and growing adoption o…

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