Hologic applies for pooled COVID-19 testing nod | Medical Design and Outsourcing

hologic applies for pooled covid-19 testing nod | medical design and outsourcing


Hologic  (NSDQ:HOLX) announced today that it has self-validated use of its Aptima and Panther Fusion molecular diagnostic COVID-19 assays with pooled patient samples and applied for an FDA emergency use authorization (EUA) for pooled testing.Marlborough, Mass.-based Hologic is the third major company to announce it is seeking such authorization. Quest Diagnostics (NYSE:DGX) gained a pooled-sample testing EUA in July, as did LabCorp, in an EUA reauthorization. Dr. Anthony Fauci, the nation’s leading infectious disease specialist, started publicly discussing the testing method in June.
The FDA is touting pooled-sample testing as more efficient than individual tests, meaning fewer testing supplies are used and more tests can be run at the same time, allowing patients to receive their results more quickly in most cases. Pooled testing is most efficient in areas with low prevalence, meaning most results are expected to be negative, according to the agency.
Quest’s authorization permits the pooled testing of up to four individual swab specimens from patients suspected of having COVID-19; LabCorp’s EUA allows for five specimens per testing pool, as would Hologic’s. In cases of a positive result, all five samples would be re-tested individually to determine which patient …



Canon Medical partners with Israeli MedTech to empower AI-driven diagnostics and care

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For years Canon Medical Systems has been innovating the MedTech scene. Now, the U.S.medical technology branch announces a partnership with Israeli healthtech startup Zebra Medical Vision in an effort to provide patients with the latest AI-driven medical solutions. The joint venture will see the Israeli startup offer its AI1 automated imaging analysis system paired with Canon’s global reach and expertise, providing physicians with accurate diagnosis for optimal medical care. Zebra Medical’s AI1 product is just one out of 6 FDA-approved products introduced by the Israeli startup. The AI-powered technology scans medical images, then runs them through cloud-based analysis to accurately diagnose and prioritize risk for a patient. The partnership moves Zebra’s AI analysis solution just one step closer to the point of care. Possibly foretelling of a future where medical conditions and treatments are determined fully by Artificial Intelligence. “We are excited about the partnership with Canon Medical Systems USA, Inc., a company taking innovative and proactive steps to ensure AI adoption for better patient care. The integration of our solution into the modality space allows us to realize Zebra Medical’s vision of improving patient care at scale. Thanks to the strong product integration between …


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Smart Diagnostic Devices Help Ease the Burden on Healthcare Systems

smart diagnostic devices help ease the burden on healthcare systems


NEW YORK, Aug. 11, 2020 /PRNewswire/ — Some of the most promising, high-growth-opportunity segments in the medical device market by application include surgical and infection control devices, general medical devices, cardiovascular devices, orthopedic devices and wearable monitoring healthcare technologies. Wearables, in particular, are a new trend that has been evolving in the medical technology sector in recent years. Wearable technologies allow for constant and remote monitoring of biochemical parameters, as well as human physical activities and behaviors. The most commonly measured data include vital signs such as heart rate, blood pressure, and body temperature, as well as blood oxygen saturation and glucose levels. Overall, the global wearable medical device market size is expected to reach USD 29.6 Billion by 2026 and expand at a Compound Annual Growth Rate (CAGR) of 17.7%, according to Transparency Market Research. Nemaura Medical, Inc. (NASDAQ: NMRD), Abbott Laboratories (NYSE: ABT), Masimo Corporation (NASDAQ: MASI), Livongo Health, Inc. (NASDAQ: LVGO), DexCom, Inc. (NASDAQ: DXCM)The recent pandemic, which has put a heavy toll on our economy and pushed the healthcare system into a severe scarcity problem, further illustrates the importance of wearable remote monitoring devices. This is also reinforced by the fact that wearable devices are expected to become significantly smarter. …


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IRRAS Announces First Global Patient Treatment with Newly Developed Hummingbird Solo ICP Monitoring System

irras announces first global patient treatment with newly developed hummingbird solo icp monitoring system


STOCKHOLM, Aug. 11, 2020 /PRNewswire/ — IRRAS AB, a commercial-stage medical technology company with a comprehensive portfolio of innovative products for neurocritical care, today announced the first patient treatment using the Hummingbird Solo, an additional line extension to its innovative Hummingbird ICP Monitoring product family that was launched in December of last year. Hummingbird Solo is a single-lumen, bolt-based monitor that measures the pressure within a patient’s brain tissue and helps diagnose and manage patients’ intracranial pressure (ICP) after traumatic brain injury (TBI), a subarachnoid hemorrhage, or stroke.
The first Hummingbird Solo patient was treated by a team, led by neurosurgeon Dr. Andrew Carlson, at the University of New Mexico (UNM) Hospital, located in Albuquerque, New Mexico.
“The Hummingbird Solo bolt’s simple insertion and set up allow us to quickly and confidently monitor critically ill patients who suffer from traumatic brain injury,” said Dr. Carlson, assistant professor of neurological surgery, UNM Hospital. “Our mission at UNM Hospital is to provide our patients with the best quality in healthcare, and we are proud to be the first hospital in the world to use this next-generation technology.”
Traumatic brain injury is defined as an impact to the head that disrupts the normal function of …


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OssDsign AB signs business partner agreement with Muranaka Medical Instruments Co., Ltd., in Japan

ossdsign ab signs business partner agreement with muranaka medical instruments co., ltd., in japan


STOCKHOLM, Aug. 11, 2020 /PRNewswire/ — OssDsign AB (Publ) (“OssDsign”) today announced that the company has signed a business partner agreement with Muranaka Medical Instruments Co., Ltd., (“Muranaka”), a pre-eminent medical product distributor in Japan. Muranaka will represent OssDsign commercially in Japan, driving adoption and sales of OssDsign’s regenerative implants for cranial reconstruction. Launching OssDsign Cranial in Japan with a national business partner is a key priority for OssDsign in 2020. The distribution agreement with Muranaka means that the company has reached a major milestone, and mutual launch preparations are now being initiated. 


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SoftBank Claws Back Into the Black After Historic Losses

softbank claws back into the black after historic losses


TOKYO — Just four months ago, Masayoshi Son, the daring billionaire who leads the Japanese conglomerate SoftBank, looked as if he might lose it all. His company had just announced the largest annual loss of any firm in the history of corporate Japan. And tens of billions of dollars in investments he had made in high-tech industries like ride-sharing and hospitality looked set for even more devastating losses as the coronavirus pandemic limited the movement of much of humanity.But on Tuesday, SoftBank declared a seemingly miraculous turnabout: It announced that it had already swung back into the black, posting a $12 billion net profit for the three-month period that ended in June. A potpourri of factors pushed SoftBank back into profitability, including aggressive asset sales, successful initial public offerings by firms in which it has invested, and stock prices for its publicly traded companies that have seemingly been divorced from the reality of a cratering global economy. Some of those companies are trading at higher levels than they were before the pandemic.The whiplash change in fortune, more rocket launch than roller coaster, highlights the volatility of financial markets in the era of the coronavirus. It also shows how a company …


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Positivity rates: State average up, local numbers down

positivity rates: state average up, local numbers down


HOUSTON – While local statistics show an apparent downturn for the COVID-19 positivity rate, the same rate at the state level continues to rise.On Monday, medical experts said says answering the “why” is not easy, partly because how the state collects its data, which also hasn’t been easy. A positivity rate is the percentage of people who test positive for a virus. The COVID-19 positivity rate is the number of new daily cases divided by the number of daily viral test results. As KPRC 2 reported, the state positivity rate continues to climb, medical leaders are not sure why that’s the case. READ: Medical leaders not clear why COVID-19 positivity rate climbing in TexasAs of Monday, the statewide positivity rate is 20.99%.The Texas Department of State Health Services publishes the state’s positivity rate daily, among other key metrics used to gauge COVID-19′s grip.As for the month of August, the state health department reports the following:Aug. 9: 20.99%Aug. 8: 20.3%Aug. 7: 19.41%Aug. 6: 16.79%Aug. 5: 17.05% As of Monday, Houston’s positivity rate is 14.6%, according to the local health department.The seven-day trend among daily positivity rates reported by the city of Houston continued to decline Monday, although far from the preferred …


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Minnesota exports drop 17% because of the coronavirus

minnesota exports drop 17% because of the coronavirus


The COVID-19 pandemic has pummeled Minnesota exports, crushing big production sectors such as communications equipment and agricultural and construction machinery.

Overall, government statistics show the state’s exports were down more than $339 million, or 17%, in June 2020 compared with June 2019.

But critical industries fared worse than the average, according to a spreadsheet assembled by the Trade Partnership, a group that analyzes data and promotes international trade.

“Minnesota’s exports have done better than most states this year falling around 17% in April, May and June,” said Dan Anthony, Trade Partnership vice president, “but still much worse than any recent period besides 2009.”

Exports in Minnesota’s communications equipment sector shrank by 76%. Agricultural machinery and construction equipment exports were down by nearly half of what they were in June 2019.

Nationally, 45 states saw exports shrink at least 10% in June compared with the same month in 2019, the Trade Partnership reported. Exports were down in 85% of the country’s congressional districts.

All eight of Minnesota’s congressional districts suffered declines in exports. The losses ranged from 20.2% in the Fourth Congressional District, which includes most of St. Paul and its suburbs, to 13.6% in the Sixth District, which includes the far west suburbs and St. Cloud.

At this point, pandemic-driven losses of exports are …


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