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Diagnostics

BlueStar Genomics gains breakthrough nod for pancreatic cancer test

March 31, 2021 By Sean Whooley

Bluestar Genomics

Bluestar Genomics announced today that it received FDA breakthrough device designation for its pancreatic cancer test. San Diego-based Bluestar’s proprietary noninvasive pancreatic cancer detection test is designed for use with patients with new-onset diabetes, according to a news release. The test uses a standard blood draw to assess whether an individual has an abnormal epigenomic […]

Filed Under: Clinical Trials, Diabetes, Diagnostics, Featured, Food & Drug Administration (FDA), Regulatory/Compliance Tagged With: Bluestar Genomics, FDA

How CGM tech has advanced in the 21st century

March 11, 2021 By Brian Buntz

CGMs Diabetes 21st Century Dexcom Medtronic Abbott Senseonics

The rapid evolution of the continuous glucose monitor (CGM) has brought flexibility and convenience to diabetes control. Continuous glucose monitors (CGMs) have transformed how many people with diabetes manage blood sugar, but attempts to monitor blood glucose have a long history. Efforts to manage glucose kicked off in earnest when researchers began measuring glucose in […]

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Filed Under: Diabetes, Diagnostics, Drug-Device Combinations, Featured Tagged With: abbott, CGM, Dexcom, Medtronic, Senseonics

PerkinElmer completes Oxford Immunotec acquisition

March 9, 2021 By Sean Whooley

PerkinElmer oxford immunotec

PerkinElmer (NYSE:PKI) announced today that it completed its previously announced acquisition of Oxford Immunotec. Under the acquisition agreement announced in January, London-based Oxford Immunotec’s shareholders will be entitled to receive $22 for each outstanding ordinary share, with the terms of the acquisition valuing Oxford Immunotec’s entire issued and to-be-issued ordinary share capital at $591 million. […]

Filed Under: Business/Financial News, Diagnostics, Drug-Device Combinations, Featured, Mergers & Acquisitions, Respiratory Tagged With: Oxford Immunotec, perkinelmer

Navidea enters into $5M private placement

March 2, 2021 By Sean Whooley

Navidea Biopharmaceuticals

Navidea Biopharmaceuticals (NYSE:NAVB) announced today that it entered into a private placement worth $5 million. Dublin, Ohio-based Navidea’s agreement comes with its largest shareholder, John K. Scott, Jr., for the purchase of $5 million in newly-designated Series E redeemable convertible preferred stock, according to a news release. Over the course of the next 18 months, the […]

Filed Under: Business/Financial News, Diagnostics, Drug-Device Combinations, Featured, Funding Roundup, Pharmaceuticals Tagged With: Navidea Biopharmaceuticals

PerkinElmer to acquire Oxford Immunotec

January 7, 2021 By Sean Whooley

PerkinElmer oxford immunotec

PerkinElmer (NYSE:PKI) and Oxford Immunotec announced today that they agreed to terms under which the former will acquire the latter. Under the agreement, London-based Oxford Immunotec’s shareholders will be entitled to receive $22 for each outstanding ordinary share, with the terms of the acquisition valuing Oxford Immunotec’s entire issued and to-be-issued ordinary share capital at $591 […]

Filed Under: Business/Financial News, Diagnostics, Drug-Device Combinations, Featured, Mergers & Acquisitions, Respiratory Tagged With: Oxford Immunotec, perkinelmer

Biolinq names new CEO

November 12, 2020 By Sean Whooley

Biolinq

Wearable biosensor technology developer Biolinq announced today that it named Richard Yang as its new CEO. San Diego-based Biolinq, which develops biosensor platforms to measure continuous glucose for managing diabetes, among other clinical conditions, said in a news release that Yang is a veteran of more than 20 years with time spent at top-tier medical device companies. […]

Filed Under: Diabetes, Diagnostics, Featured, Personnel Tagged With: biolinq

Abbott’s FreeStyle Libre 3 receives CE Mark

September 28, 2020 By Chris Newmarker

Abbott FreeStyle Libre 3 sensor pennies CGM diabetes

Abbott (NYSE:ABT) has won the CE Mark in the European Union for its next-generation FreeStyle Libre 3 continuous glucose monitoring system. Officials at Abbott boast that the Libre 3 technology includes a super small, thin sensor. It’s the size of two U.S. pennies stacked together and able to accurately provide real-time glucose readings over 14 days […]

Filed Under: Business/Financial News, Diabetes, Diagnostics, Featured, Regulatory/Compliance Tagged With: abbott, Abbott Laboratories

PerkinElmer launches high-volume COVID-19 test workstations

August 17, 2020 By Sean Whooley

PerkinElmer

PerkinElmer (NYSE:PKI) announced today that it launched a series of Explorer workstations for increasing COVID-19 testing capabilities. Waltham, Mass.-based PerkinElmer touts its Explorer workstations as capable of preparing and running up to 10,000 COVID-19 tests per day, enabling laboratories to ramp up their testing for the SARS-CoV-2 virus causing coronavirus and generate quick results. According to […]

Filed Under: Business/Financial News, Diagnostics, Featured Tagged With: coronavirus, COVID-19, perkinelmer

BREAKING: Thermo Fisher drops bid for Qiagen

August 13, 2020 By Sean Whooley

Thermo Fisher Scientific (NYSE:TMO) announced today that its offer to acquire Qiagen (NYSE:QGEN) in an $11.5 billion deal has lapsed. According to a news release, more than 107.5 million shares of Qiagen (47.02% of the issued and outstanding ordinary shares for the company) were validly tendered into the offer by the end of the acceptance period on Aug. […]

Filed Under: Business/Financial News, Diagnostics, Featured, Mergers & Acquisitions, Wall Street Beat Tagged With: qiagen, thermofisherscientific

Report: Will Dr. Hahn crack under political pressure?

August 10, 2020 By Nancy Crotti

Many jobs have come with increased stress levels during the coronavirus pandemic, from ICU staff to Walmart greeters. Now officials who’ve been keeping tabs on FDA commissioner Dr. Stephen Hahn are wondering whether he can weather the strain of defending science while working for the Trump administration. Hahn has been squeezed between expressing his professional […]

Filed Under: Diagnostics, Featured, Food & Drug Administration (FDA), Pharmaceuticals Tagged With: Centers for Disease Control & Prevention, coronavirus, COVID-19, Donald Trump, FDA, U.S. Department of Health & Human Services

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