medical device – Page 4 – media

FDA Considering Comments on SaMD Precertification Program

Healthcare industry stakeholders say the FDA should consider a type of measuring stick when evaluating a vendor’s cybersecurity culture to decide whether it meets the requirements for the agency’s proposed fast-past program for premarket approval of "software as a medical device" products (SaMD). Until the end of the last month, the FDA accepted proposals on its working model for a SaMD pre-approval program
- Source: Healthcare Info Security
- 730
- June 14, 2018
digital health FDA Market Views medical device
Airo CT Imaging For Pediatrics

It has been reported that the FDA has granted the approval of Mobius Imaging, LLC based Airo CT imaging utilization for pediatric patients. These pediatric patients can receive the clinical benefits of Airo CT imaging for diagnostic and intraoperative procedures hereafter.
- Source: MPO mag
- 774
- June 13, 2018
CT scanner medical device New Approvals
FDA Recalls HeartMate device Manufactured by Abbott

This will be the second recall on a heart device this month Medtronic’s Heartware device and accessories was recalled a few days ago. This comes after Abbott issued a patch to negate cybersecurity issues 350,000 remote monitoring systems and pacemakers.
- Source: Ddu
- 709
- June 7, 2018
Abbott Company Insight heart failure medical device
Niti Aayog Planning to Improve Indian Medical Devices Sector

Niti Aayog is focusing on proposals to encourage domestic manufacturing of medical devices following orders from the Prime Minister's Office, said the expert. The meeting was focused on identifying the problems in local manufacturing and quality of the devices produced in India and also to spot the solution for the issues.
- Source: Ddu
- 842
- May 31, 2018
India Market Views medical device
Ultrasounds Systems to Augment Competencies of Healthcare Sector

The global ultrasounds systems marker is expected to clock a market value in excess of over USD 12,500 million by the end of 2028, recording a CAGR of 5.7% in the forecast period as per findings of global forecasts stated in the report titled 'Ultrasound Systems Market - Global Industry Analysis 2013 - 2017 and Opportunity Assessment 2018 - 2028'.
- Source: Ddu
- 592
- May 23, 2018
Market Views medical device ultrasound
Operating Room Equipment Market Holds Immense Potential

In 2017, the movable imaging systems segment generated revenue of US$8,384.9 million and held a solid position in the operating room equipment segment.
- Source: Ddu
- 754
- May 22, 2018
Market Views medical device
Genesis Innovation Invests in Shoulder Innovations

Holland-based Genesis Innovation Group LLC raised $7.2 million of its $10 million goal toward a fund to invest in early-stage healthcare companies developing medical devices and orthopedic technologies.
- Source: drugdu
- 735
- May 21, 2018
Company Insight medical device orthopaedic technology
The imperative for securing connected medical devices

The implementation of privacy protocols and security controls is pertinent to protecting patient records and sensitive data. However, the threat to patient safety, the core of every modern health system, being compromised is growing rapidly owing to network-connected medical devices.
- Source: Ddu
- 679
- May 17, 2018
digital health Market Views medical device
FDA Approves Qiagen’s PartoSure for Preterm Labor

On April 20, 2018, Qiagen announced the FDA approval of the novel test named PartoSureTM, used for assessing the risk of spontaneous preterm birth in patients with symptoms of preterm labor.
- Source: Ddu
- 637
- May 17, 2018
medical device New Approvals preterm labor
New Sensor Detects Arsenic Contamination in One Min

Scientists from the Department of Chemistry at Imperial have developed a small, user-friendly, accurate and cost-effective sensor to test arsenic levels in drinking water within a minute. When a drop of water hits the test strip, it gives the arsenic level count digitally.
- Source: Ddu
- 744
- May 17, 2018
arsenic trioxide medical device New Approvals

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