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Home » Topics » Medical devices and technologies » Diagnostics

Diagnostics
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Shanghai, China, stock market illustration

Assure Tech raises $188M in Shanghai IPO

Nov. 19, 2021
By Doris Yu
Assure Tech (Hangzhou) Co. Ltd. made its debut on the Shanghai Stock Exchange Star Market and raised ¥1.2 billion (US$188 million) in the IPO. Its shares increased 19.28% in the middle of the first trading day but closed 6.73% lower the second day.
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Gloved hand holding Veros platform

$65M investment says instrument-free COVID-19 testing makes Sense

Nov. 18, 2021
By Annette Boyle
Sense Biodetection Ltd. closed a $65 million series B investment round on a high note with an additional $15 million pouring in from previous investors. The Abingdon, England-based company raised $50 million in a first tranche of the round in April. Koch Disruptive Technologies LLC, a subsidiary of Koch Industries Inc., led both parts of the round.
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Image of Celtivity system in use

Aquyre raises $20M for on-site biopsy analysis platform

Nov. 17, 2021
By Annette Boyle
Aquyre Biosciences Inc., formerly known as Lltech, raised $19,945,534 in a series A2 preferred stock financing round to fund commercialization of its Celtivity system for on-site adequacy assessments of tissue biopsies. Ceros Financial Services acted as placement agent for more than $17.14 million of the funds raised in this round as part of its recently announced commitment to raise $100 million in the next 12 months for investment in early-stage medical technology and medical device companies.
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Tumor microenvironment image obtained using multiphoton microscopy and endogenous fluorescence

Oncocyte launches immunotherapy response prediction test to bring cancer cells out into the open

Nov. 17, 2021
By David Godkin
TORONTO – Oncocyte Corp. launched Determaio, an immunotherapy response prediction test it said is “the first to comprehensively assess the tumor microenvironment.” This is important because of how smart cancer cells are in that microenvironment, Oncocyte CEO Ronnie Andrews told BioWorld, commandeering natural tissue repair biology and condensing immunological T cells so they back off attacking cancerous tissue.
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U.K. study illuminates value of whole genome sequencing in rare disease care

Nov. 17, 2021
3D illustration of chromosomes

China’s first PGT-A test that helps couples select healthy embryos gets NMPA approval

Nov. 16, 2021
By Doris Yu
Peking Jabrehoo Med Tech Co. Ltd.’s genetic testing kit won marketing approval from China’s NMPA. It is the first preimplantation genetic testing for aneuploidy (PGT-A) that uses the reversible termination sequencing method in China, according to the company.
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US flag, Department of Health and Human Services flags

HHS withdraws rescission of FDA authority to regulate lab-developed tests

Nov. 15, 2021
By Mark McCarty
The U.S. Department of Health and Human Services (HHS) has withdrawn its August 2020 rescission of the FDA’s authority to regulate lab-developed tests (LDTs), a reversal predicated on the need for additional testing capacity for the COVID-19 pandemic. However, the non-COVID implications are not clear as the FDA is not widely seen as having the capacity to regulate LDTs for non-pandemic purposes, while pending legislation would dramatically overhaul the agency’s approach to LDT regulation, making the current regulatory environment an unstable environment at best. The FDA accompanied the announcement with a statement that the emphasis at the agency is on tests that do not require that the patient sample be sent to a lab for processing.
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Ellume COVID-19 Home Test packaging

FDA upgrades Ellume COVID-19 test recall to ‘most serious’

Nov. 12, 2021
By Annette Boyle
The FDA categorized the recall of more than 2.2 million Ellume Pty Ltd. COVID-19 Home Tests that began Oct. 5 as a class I recall, “the most serious type of recall.” While the agency has received significant criticism lately about ambiguity in recalls that often leaves consumers uncertain about their seriousness, the FDA eliminated all doubt on this one saying, “use of these tests may cause serious adverse health consequences or death.” The FDA said it received 35 reports of false positives associated with the antigen test. No deaths have been reported.
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Heart rate illustration

Heartbeam struggles to shine in $16.5M IPO

Nov. 12, 2021
By Catherine Longworth
Shares of cardiac diagnostics company Heartbeam Inc. (NASDAQ:BEAT) are trading lower than expected after it opened on the Nasdaq on Nov. 11. The digital health company priced its public offering of 2,750,000 units at $6, but as of midday, shares were trading at $4.56. It’s a disappointing start for the Santa Clara, Calif.-based company, which is developing an ECG telemedicine technology to diagnose cardiovascular patients for ambulatory settings.
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T-cell findings suggest pan-coronavirus vaccine approach for SARS-CoV-2, variants

Nov. 11, 2021
By Nuala Moran
LONDON – Intensive monitoring of health care workers at two hospitals in London showed that despite having a blood biomarker of infection, 58 of them did not test positive for COVID-19 at any point, suggesting they may have been clearing subclinical infections before seroconversion.
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