3 medtech execs make EY entrepreneur finalist list

A trio of Minnesota medtech business leaders has landed on the finalist list for EY Entrepreneur of the Year 2021 Heartland.

Executives from AbiliTech Medical, Minnesota Rubber & Plastics and TSI rank among the 36 finalists from Iowa, Kansas, Minnesota, Missouri, Nebraska, North Dakota and South Dakota. The finalists were selected by a panel of independent judges, according to EY.

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

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Cleerly launches digital heart attack prevention software following $43M Series B

Cleerly today said it has launched its digital care software for heart attack prevention following a $43 million Series B funding round.

New York-based Cleerly’s digital care technology is a non-invasive coronary computed tomography angiography that performs coronary artery phenotyping through artificial intelligence. According to the company, it uses millions of annotated lab images to build more than two dozen algorithms that quantify and characterize the presence, extent, severity and type of coronary artery disease and other cardiovascular diseases.

“Advanced imaging has been key to diagnosing and preventing the most common causes of cancer for years, but we’re not using it yet to prevent the most common cause of death. We use 3D mammograms, colonoscopies and lung CT scans to find and prevent breast, colon and lung cancer, but we haven’t had similar capabilities for the world’s number one killer – heart disease,” CEO James Min said in a news release. …

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How to choose the right printing technology for UDI codes

UDI labeling can identify medical devices through their distribution and use. The deadline for labeling Class 1 and unclassified devices is coming up.

Tim Kearns, Videojet Technologies

A Videojet Wolke m610 oem thermal inkjet printer [Image courtesy of Videojet]

Whether you are expanding the production of medical devices already subject to Unique Device Identification (UDI) requirements or finishing your plan to meet the FDA’s UDI requirements for Class I devices, you’ll want to attain high-resolution printing of variable codes on devices and their packaging.

UDI paves the way for traceability

To improve medical device traceability, the FDA established the UDI system and implemented it in phases, beginning in 2014. While the agency delayed UDI compliance for Class I and unclassified devices until September 2022, full compliance for medical devices in Class II and III and implantable life-supportin…

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Agios Pharmaceuticals files NDA for drug that would treat pyruvate kinase deficiency

The small-molecule therapeutics company Agios Pharmaceuticals (NSDQ:AGIO) has submitted a new drug application (NDA) with the FDA to use mitapivat to treat adults with pyruvate kinase (PK) deficiency, a rare condition in which the rapid breakdown of red blood cells occurs can trigger anemia. The condition is the result of an inherited lack of the enzyme PK.

Mitapivat is a novel oral, small molecule allosteric activator of wild-type and various mutated PKR enzymes.

“With this NDA filing, we are poised to deliver the first potentially disease-modifying therapy for people with PK deficiency, a chronic, lifelong hemolytic anemia characterized by serious complications affecting multiple organs,” said Dr. Chris Bowden, the chief medical officer at Agios.

There are currently no FDA-approved therapies for PK deficiency. While mild cases may not require treatment, physicians treat more severe forms of the disease with blood transfusions and splenectomy. PK defici…

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White House allocates 55M COVID-19 vaccine doses for global distribution

[Photo by Daniel Schludi on Unsplash]The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

Get the full story at our sister site, Pharmaceutical Processing World.

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White House to allocate 55M COVID-19 vaccine doses for global distribution

The Biden-Harris administration today announced a global distribution list for 55 million doses of America’s COVID-19 vaccine supply.

Biden pledged to allocate 80 million doses of the COVID-19 vaccine supply belonging to the U.S. by the end of June to aid the global fight against the pandemic. Earlier this month, the administration announced the plan for the first 25 million doses that the U.S. has begun shipping, with the remaining 55 million doses announced today.

According to a news release, the U.S. will share 75% of the 80 million through COVAX and 25% are earmarked to help with surges around the world. The doses are slated to be allocated based on national vaccine plans, prioritizing those most at risk, including healthcare workers.

The allocation plan for the 55 million doses announced today includes 41 million to be shared through COVAX, with 14 million for Latin America and the Caribbean, with doses going to Brazil, Argentina, Brazil, Arge…

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U.S. Supreme Court kicks Arthrex case back to patent board

The U.S. Supreme Court ruled today that Patent Trial and Appeal Board judges are unconstitutionally appointed, but that greater supervision by the PTAB director would solve the problem.

The opinion in the case followed a 2019 appeals court ruling in the closely watched patent spat between Arthrex and Smith+Nephew (NYSE:SNN). In the original lawsuit, Smith+Nephew and ArthroCare (which Smith+Nephew acquired in 2014) petitioned for inter partes review of a patent secured by Arthrex. Three patent judges concluded that the patent was invalid.

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Australia COVID-19 vaccine supply limited until August

Australia image from Pixabay.

As the U.S. sees demand plateauing for COVID-19 vaccines, Australia is facing a shortage of both vaccine supplies and healthcare workers.

Australian health officials project that the nation’s vaccination program will face delays from June to July. The slowdown is partly a result of limited shipments of the Pfizer vaccine. Australia expects to receive 1.7 million doses of the vaccine this month and another 2.8 million in July.

Australian officials are also aiming to enlist a greater number of general practitioners to help dispense vaccines later in the summer when supplies are likely to increase.

Like several other countries, Australia has also limited the use of the AstraZeneca (LON:AZN) vaccine over the risk of rare blood clots. Health officials there recently recommended the AstraZeneca vaccine only for adults 60 and older.

Australia’s Chief Medical Office…

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Athira Pharma faces shareholder rights investigations

A growing number of law firms are investigating claims of securities fraud associated with Athira Pharma (NSDQ:ATHA), a clinical-stage biopharma focused on small molecules targeting neurodegeneration. Its lead therapeutic candidate, ATH-1017, targets dementia associated with Alzheimer’s and Parkinson’s.

Law firms investigating potential securities fraud claims involving the company include the following:

Ademi (Milwaukee). Block & Leviton (Boston). Johnson Fistel (San Diego). Portnoy (Los Angeles). Wolf Popper (New York City).

The Bothell, Wash.–based company’s stock fell 39% on June 18 after announcing it was putting Leen Kawas, the firm’s CEO, on temporary leave.

Its share price had stabilized in mid-day trading, edging up 1% to $11.27. E

arlier this month, Jefferies predicted thath Athira shares would rise as much as 50% after FDA decided to approve the Alzheimer’s drug aducanumab from Biogen (NSDQ:BIIB).

An Athira Pharma spo…

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Medtronic wins expanded FDA approval for cryoablation catheters

Medtronic (NYSE:MDT) announced today that it received FDA expanded approval for its Arctic Front family of cardiac cryoablation catheters.

Fridley, Minn.-based Medtronic’s Arctic Front family of catheters treat recurrent symptomatic paroxysmal atrial fibrillation (AFib) as an alternative to antiarrhythmic drug (AAD) therapy as an initial rhythm control strategy.

Get the full story at our sister site, Medical Tubing & Extrusion.

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Ethicon launches curved jaw tissue sealer

[Image from Ethicon]Ethicon — part of Johnson & Johnson (NYSE:JNJ) — announced today that it launched the Enseal X1 curved jaw tissue sealer.

Cincinnati-based Ethicon developed the Enseal as a new advanced bipolar energy device designed to increase procedural efficiency and provide stronger sealing and better access to more tissue than Medtronic’s LigaSure Maryland, according to a news release.

Indications for the device include colorectal, gynecological, bariatric surgery and thoracic procedures. It includes separate seal and cut capabilities, a 360-degree continuous shaft rotation that enables easy access to targeted tissue. Ethicon’s adaptive tissue technology allows the device to continuously sense changes in the condition of tissue and respond accordingly with the optimal amount of energy to minimize lateral thermal spread.

Enseal X1 curved jaw marks the first of a series of new advanced laparoscopic bipolar devices set to launch from E…

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FDA clears Masimo wearable thermometer for prescription, OTC use

[Image from Masimo]Masimo (NSDQ:MASI) announced today that it received FDA 510(k) clearance for two uses of its Radius Tº wearable thermometer.

Irvine, Calif.-based Masimo clearances for Radius Tº cover both prescription use and over-the-counter use for patients and consumers five years of age and older, according to a news release.

Radius Tº includes continuously trending temperature measurements and Bluetooth connectivity for automating remote, continuous body temperature status through a paired connection to a Masimo patient monitoring or telehealth solution in patients. Consumers track temperature status through the Radius Tº smartphone application.

For prescription use, Radius Tº is compatible with the Root patient monitoring and connectivity hub and the Rad-97 patient monitor. It can also be paired with the Masimo SafetyNet app for remote patient management from the home or other care locations.

It offers streamlined workflows, convenient weara…

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