Diagnostics: Page 3

Senseonics lands CE mark for 6-month CGM implant, teeing up Q3 launch in Europe

Senseonics is looking to the longer-lasting implant to re-energize its fight in a market dominated by Abbott Laboratories and Dexcom.

By Nick Paul Taylor • June 17, 2022

User fee package goes to Senate with lab-developed test, OTC hearing aid provisions

The Senate HELP committee passed its version of the FDA user fee bill by a 13-9 vote. It includes an overhaul of diagnostic testing regulations and a requirement to create a category of over-the-counter hearing aids.

By Elise Reuter • June 15, 2022

Explore the Trendline➔

Medical device industry continues to turn to digital health, AI

While the industry continues to embrace digital health and artificial intelligence, there are still questions about how the new technologies and services need to be regulated and if they are effective.

By MedTech Dive staff

DHS warns cybersecurity vulnerabilities in Illumina software could affect test results

Three of the flaws outlined by the Department of Homeland Security received the highest risk score. Vulnerabilities could allow attackers to remotely alter the results generated by Illumina products.

By Nick Paul Taylor • June 6, 2022

GE Healthcare says contrast media production back to full capacity

The shortage of the injectable used for medical imaging started in April, when the company’s plant in Shanghai shut down due to rising COVID-19 cases.

By Nick Paul Taylor • Updated June 17, 2022

FDA to start accepting all pre-submissions for in vitro diagnostics

The agency had previously declined pre-submission requests unless they were related to COVID-19. Test developers should expect an extended timeline for reviews amid a backlog of pandemic-related submissions. 

By Elise Reuter • June 1, 2022

Baxter raises forecasts for Hillrom synergies, allaying concerns over $10.5B takeover

Company executives said the additional cost savings emerged as they took a closer look at Hillrom’s real estate footprint.

By Nick Paul Taylor • May 26, 2022

Proposed LDT regulations has diagnostics industry, consumer groups at odds

Consumer advocates say the proposed legislation has too many exemptions and doesn’t provide adequate protections for patients, while industry groups seek to limit premarket review requirements of legacy tests.

By Elise Reuter • May 25, 2022

Medtech companies keep supply, staffing challenges in check even as recession risks loom: analysts

Companies are coping with factors such as supply disruptions, staffing shortages, inflation and foreign-exchange hurdles, according to William Blair analysts.

By Nick Paul Taylor • May 24, 2022

Senate seeks to reform diagnostic oversight via user-fee bill, sparking mixed response

The revised bill from the Senate features a modified version of the Verifying Accurate Leading-edge IVCT Development Act that split the diagnostic industry when lawmakers previously tried to pass it.

By Nick Paul Taylor • May 23, 2022

FDA user-fee bill goes to House; Senate committee draft revamps diagnostic regulations

The House Energy and Commerce Committee unanimously passed a bill to reauthorize the FDA’s user-fee amendments for the next five years. A Senate committee draft of the bill would add substantive changes.

By Elise Reuter • May 19, 2022

LabCorp becomes first company to get EUA for direct-to-consumer test for flu, RSV, COVID-19

The kit allows individuals to self-collect nasal swab samples at home to send to LabCorp, which will test for the presence of influenza A and B, respiratory syncytial virus and SARS-CoV-2.

By Nick Paul Taylor • May 18, 2022

FDA posts Class I recall report for 51,000 rapid antigen COVID-19 tests

Woodside Acquisitions recalled two different rapid antigen test kits last month and sent emails to distributors requesting them to immediately return all unused products for a refund.

By Nick Paul Taylor • May 16, 2022

FDA needs testing enforcement discretion policy to improve crisis response, GAO finds

The U.S. Government Accountability Office has recommended that the FDA develop a policy about when to start and stop enforcement discretion for unauthorized tests to avoid some of the problems it faced during the pandemic.

By Nick Paul Taylor • May 13, 2022

Hologic gets FDA approval to challenge Abbott, Roche in transplant testing market

The company plans to work toward approvals of transplant assays for other pathogens including the BK virus and Epstein-Barr virus to provide quantitative assessments of potential threats to patients.

By Nick Paul Taylor • May 12, 2022

Roundup: As procedures rebound, supply chain, staffing challenges set to continue for medtechs

Procedure-driven companies saw sales recover at the end of the first quarter, while diagnostics businesses reported increased sales of COVID-19 tests due to the omicron surge in January.

By Elise Reuter • Updated May 19, 2022

Earnings week 3: Procedure rebounds, stock price declines, iRhythm's comeback

AtriCure and Axonics reported procedure volume rebounds and both firms increased their 2022 forecasts. Still, the share prices of the companies dropped late last week.

By Ricky Zipp • May 9, 2022

EU task force posts guidance on significant IVDR changes to address a top priority for industry

The guidance will help manufacturers determine if a change to an in-vitro diagnostic is significant and will require certification by a notified body after the new regulations go into effect on May 26. 

By Nick Paul Taylor • May 6, 2022

FDA reveals another Class I COVID-19 test recall as SML pulls 209,000 kits from the market

The SML notice comes one week after the FDA shared details of a recall of 311,100 Celltrion tests that may have been sent to unauthorized users that lack CLIA certification.

By Nick Paul Taylor • May 5, 2022

FDA clears Abbott's 4-in-1 Alinity PCR test for sexually transmitted infections

Abbott is pitching the assay as a way for healthcare providers to gain a fuller picture of a person’s health from a single test and create the optimal treatment plan.

By Nick Paul Taylor • May 5, 2022

Hologic, Thermo Fisher, Qiagen quarterly sales beat estimates on COVID-19 test revenue

Still, the companies warned demand for testing will decline quickly for the remainder of 2022. 

By Nick Paul Taylor • May 3, 2022

FDA labels Celltrion's latest recall of 310,000 COVID-19 tests as a Class I event

The recall stems from the fact that the emergency authorization of the Point of Care DiaTrust COVID-19 Ag Rapid Test only covers use by laboratories with CLIA certification.

By Nick Paul Taylor • May 2, 2022

GE Healthcare, Medtronic turn to outpatient care in new partnership

The companies agreed to a collaboration on ambulatory surgery centers and office-based labs as more procedures are shifting to outpatient care settings. 

By Elise Reuter • April 29, 2022

ACLA, AdvaMed urge Congress to immediately replenish COVID-19 testing fund

Joining a coalition of more than 60 organizations, the lab and medtech groups warned congressional leaders the funding expiration puts the most vulnerable Americans at risk of losing resources to diagnose new infections.

By Nick Paul Taylor • April 28, 2022

GE Healthcare hit by supply chain constraints, inflation pressures

"We're operating in a challenging macro environment," GE CEO Larry Culp said during a first-quarter earnings call, while also noting COVID-19 lockdowns in China and lower sales volumes in Russia and Ukraine impacted results. 

By Greg Slabodkin • April 26, 2022

Philips commits more cash to recall as DOJ issues subpoena

The Dutch conglomerate said Monday that it is cooperating with an April 8 subpoena from the U.S. Department of Justice seeking information related to the Respironics recall of sleep apnea devices and ventilators.

By Nick Paul Taylor • April 25, 2022